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Multidisziplinäre Rehabilitation nach erworbener Hirnverletzung für Erwachsene im erwerbsfähigen Alter

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Referencias

References to studies included in this review

Andelic 2012 {published data only}

Andelic N, Bautz‐Holter E, Ronning P, Olafsen K, Sigurdardottir S, Schanke AK, et al. Does an early onset and continuous chain of rehabilitation improve the long‐term functional outcome of patients with severe traumatic brain injury?. Journal of Neurotrauma 2012;29:66‐74.
Andelic N, Ye J, Tornas S, Roe C, Lu J, Bautz‐Holter E, et al. Cost‐effectiveness analysis of an early‐initiated, continuous chain of rehabilitation after severe traumatic brain injury. Journal of Neurotrauma July 15, 2014;31(14):1313‐20.

Bai 2012 {published data only}

Bai Y, Hu Y, Wu Y, Zhu Y, He Q, Jiang C, et al. A prospective, randomized, single‐blinded trial on the effect of early rehabilitation on daily activities and motor function of patients with hemorrhagic stroke. Journal of Clinical Neuroscience 2012;19:1376‐9.

Björkdahl 2006 {published data only}

Bjorkdahl A, Lundgren NA, Grimby G, Sunnerhagen S. Does a short period of rehabilitation in the home setting facilitate functioning after stroke? A randomized controlled trial. Clinical Rehabilitation 2006;20:1038‐49.

Bowen 2001 {published data only}

Bowen A, Tennant A, Neumann V, Chamberlain MA. Neuropsychological rehabilitation for traumatic brain injury: Do carers benefit?. Brain Injury 2001;15(1):29‐38.

Cicerone 2008 {published data only}

Cicerone KD, Mott T, Azulay J, Sharlow‐Galella MA, Ellmo WJ, Paradise S, et al. A randomized controlled trial of holistic neuropsychologic rehabilitation after traumatic brain injury. Archives of Physical Medicine and Rehabilitation 2008;89:2239‐49.

Elgmark 2007 {published data only}

Elgmark Andersson E, Emanuelson I, Björklund R, Stålhammar DA. Mild traumatic brain injuries: the impact of early intervention on late sequelae. A randomized controlled trial. Acta Neurochirurgica 2007;149:151‐60.

Kwakkel 1999 {published data only}

Kwakkel G, Kollen BJ, Wagenaar RC. Long term effects of intensity of upper and lower limb training after stroke: a randomised trial. Journal of Neurology, Neurosurgery and Psychiatry 2002;72(4):473‐9.
Kwakkel G, Wagenaar RC, Twisk JWR, Lankhorst GJ, Koetsier JC. Intensity of leg and arm training after primary middle‐cerebral artery stroke: a randomised trial. Lancet 1999;354:189‐94.

Ozdemir 2001 {published data only}

Ozdemir F, Birtane M, Tabatabaei R, Kokino S, Ekuklu G. Comparing stroke rehabilitation outcomes between acute in‐patient and non‐intense home settings. Archives of Physical Medicine and Rehabilitation 2001;82:1375‐9.

Paniak 1998 {published data only}

Paniak C, Toller Lobe G, Durand A, Nagy J. A randomized trial of two treatments for mild traumatic brain injury. Brain Injury 1998;12(12):1011‐23.
Paniak C, Toller‐Lobe G, Reynolds S, Melnyk A, Nagy J. A randomized trial of two treatments for mild traumatic brain injury: 1 year follow‐up. Brain Injury 2000;14(3):219‐26.

Powell 2002 {published data only}

Powell J, Heslin J, Greenwood R. Community based rehabilitation after severe traumatic brain injury: a randomised controlled trial. Journal of Neurology, Neurosurgery and Psychiatry 2002;72(2):193‐202.

Salazar 2000 {published data only}

Braverman SE, Warden DL, Wilson BC, Ellis TE, Bamdad MJ, Salazar AM. A multidisciplinary TBI inpatient rehabilitation programme for active duty service members as part of a randomized clinical trial. Brain Injury 1999;13(6):405‐15.
Salazar AM, Warden DL, Schwab K, Spector J, Braverman S, Walter J, et al. Cognitive rehabilitation for traumatic brain injury: a randomized trial. Defense and Veterans Head Injury Program (DVHIP) Study Group. JAMA 2000;283(23):3075‐81.
Warden DL, Salazar AM, Martin EM, Schwab KA, Coyle M, Walter J. A home program of rehabilitation for moderately severe traumatic brain injury patients. The DVHIP Study Group. Journal of Head Trauma Rehabilitation 2000;15(5):1092‐102.

Semlyen 1998 {published data only}

Semlyen JK, Summers SJ, Barnes MP. Traumatic brain injury: efficacy of multidisciplinary rehabilitation. Archives of Physical Medicine and Rehabilitation 1998;79(6):678‐83.

Shiel 2001 {published data only}

Shiel A, Burn JP, Henry D, Clark J, Wilson BA, Burnett ME, et al. The effects of increased rehabilitation therapy after brain injury: results of a prospective controlled trial. Clinical Rehabilitation 2001;15(5):501‐14.

Slade 2002 {published data only}

Slade A, Tennant A, Chamberlain A. A randomised controlled trial to determine the effect of intensity of therapy upon length of stay in a neurological rehabilitation setting. Journal of Rehabilitation Medicine 2002;34:260‐6.

Smith 1981 {published data only}

Smith D, Goldenberg E, Ashburn A, Kinsella G, Sheikh K, Brennan PJ, et al. Remedial therapy after stroke: a randomised controlled trial. British Medical Journal 1981;282:517‐20.

Wade 1997 {published data only}

King NS, Crawford S, Wenden FJ, Moss NE, Wade DT. Interventions and service need following mild and moderate head injury: the Oxford Head Injury Service. Clinical Rehabilitation 1997;11(1):13‐27.
Wade DT, Crawford S, Wenden FJ, King NS, Moss NE. Does routine follow up after head injury help? A randomised controlled trial. Journal of Neurology, Neurosurgery and Psychiatry 1997;62(5):478‐84.
Wenden FJ, Crawford S, Wade DT, King NS, Moss NEG. Assault, post‐traumatic amnesia and other variables related to outcome following head injury. Clinical Rehabilitation 1998;12(1):56‐63.

Wade 1998 {published data only}

Wade DT, King NS, Wenden FJ, Crawford S, Caldwell FE. Routine follow up after head injury: a second randomised controlled trial. Journal of Neurology, Neurosurgery and Psychiatry 1998;65(2):177‐83.

Werner 1996 {published data only}

Werner RA, Kessler S. Effectiveness of an intensive outpatient rehabilitation program for postacute stroke patients. American Journal of Physical Medicine and Rehabilitation 1996;75(2):114‐20.

Zhu 2007 {published data only}

Zhu XL, Poon WS, Chan CH, Chan SH. Does intensive rehabilitation improve the functional outcome of patients with traumatic brain injury (TBI)? A randomized controlled trial. Brain Injury 2007;21(7):681‐90.
Zhu XL, Poon WS, Chan CH, Chan SH. Does intensive rehabilitation improve the functional outcome of patients with traumatic brain injury? Interim result of a randomized controlled trial. British Journal of Neurosurgery 2001;15(6):464‐73.

References to studies excluded from this review

Bjorkdahl 2007 {published data only}

Bjorkdahl A, Nilsson AL, Sunnerhagen KS. Can rehabilitation in the home setting reduce the burden of care for the next‐of‐kin of stroke victims?. Journal of Rehabilitation Medicine 2007;39:27‐32.

Browne 2013 {published data only}

Browne AL, Appleton S, Fong K, Wood F, Coll F, de Munck S, et al. A pilot randomized controlled trial of an early multidisciplinary model to prevent disability following traumatic injury. Disability & Rehabilitation 2013;35:1149‐63.

Ownsworth 2008 {published data only}

Ownsworth T, Fleming J, Shum D, Kuipers P, Strong J. Comparison of individual, group and combined intervention formats in a randomized controlled trial for facilitating goal attainment and improving psychosocial function following acquired brain injury. Journal of Rehabilitation Medicine 2008;40:81‐8.

Relander 1972 {published data only}

Relander M, Troupp H, Bjorksten G. Controlled trial of treatment for cerebral concussion. British Medical Journal 1972;4:777‐9.

Sonoda 2004 {published data only}

Sonoda S, Saitoh E, Nagai S, Kawakita M, Kanada Y. Full‐time integrated treatment program, a new system for stroke rehabilitation in Japan. Comparison with conventional rehabilitation. American Journal of Physical Medicine and Rehabilitation 2004;83(2):88‐93.

Vanderploeg 2008 {published data only}

Vanderploeg RD, Schwab K, Walker WC, Fraser JA, Sigford BJ, Date ES, et al. Rehabilitation of traumatic brain injury in active duty military personnel and veterans: Defense and Veterans Brain Injury Center randomized controlled trial of two rehabilitation approaches. Archives of Physical Medicine and Rehabilitation 2008;89:2227‐38.

References to ongoing studies

NCT00869154 {published data only}

NCT00869154. Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury. Clinicaltrials.gov (Accessed December 2015).

Ben‐Yishay 1990

Ben‐Yishay Y, Gold J. Therapeutic milieu approach to neuropsychological rehabilitation. In Woods RL, Editor. Neurobehavioural Sequelae of Traumatic Brain Injury. New York: Taylor & Francis, 1990.

Craig 2008

Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new medical research guidance. British Medical Journal 2008;337:979‐83.

DeJong 2005

DeJong G, Horn SD, Conroy B, Nichols D, Healton EB. Opening the black box of post‐stroke rehabilitation: stroke rehabilitation patients, processes, and outcomes. Archives of Physical Medicine and Rehabilitation 2005;86(12 Suppl 2):S1‐S7.

Department of Health 2005

The National Service Framework for Long‐term Conditions. Department of Health. London: Department of Health, 2005.

Gladman 1993

Gladman JR, Lincoln NB, Barer DH. A randomised controlled trial of domiciliary and hospital‐based rehabilitation for stroke patients after discharge from hospital. Journal of Neurology, Neurosurgery and Psychiatry 1993;56(9):960‐6.

Greener 2002

Greener J, Langhorne P. Systematic reviews in rehabilitation for stroke: issues and approaches to addressing them. Clinical Rehabilitation 2002;16(1):69‐74.

Higgins 2011

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. www.cochrane‐handbook.org.

Hoffmann 2010

Hoffmann T, Bennett S, Koh CL, McKenna KT. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database of Systematic Reviews 2010, Issue 9. [DOI: 10.1002/14651858.CD006430.pub2]

Horn 2005

Horn SD, DeJong G, Ryser DK, Veazie PJ, Teraoka J. Another look at observational studies in rehabilitation research: going beyond the holy grail of the randomized controlled trial. Archives of Physical Medicine and Rehabilitation 2005;86(12 Suppl 2):S8‐S15.

Horn 2007

Horn SD, Gassaway J. Practice‐based evidence study design for comparative effectiveness research. Medical Care 2007;45 Suppl 2(10):50‐7.

Kalra 1994

Kalra L. Does age affect benefits of stroke unit rehabilitation?. Stroke 1994;25(2):346‐51.

Kersten 2002

Kersten P, Lou J, Ashburn A, George S, McLellan D. The unmet needs of young people who have had a stroke: results of a national UK survey. Disability and Rehabilitation 2002;24:860‐6.

Khan 2007

Khan F, Ng L, Gonzalez S, Hale T, Turner‐Stokes L. Multidisciplinary rehabilitation programmes following joint replacement at the hip and knee in chronic arthropathy. Cochrane Database of Systematic Reviews 2008, Issue 2. [DOI: 10.1002/14651858.CD004957.pub3]

Khan 2008

Khan F, Turner‐Stokes L, Ng L, Kilpatrick T. Multidisciplinary rehabilitation for adults with multiple sclerosis. Cochrane Database of Systematic Reviews 2007, Issue 2. [DOI: 10.1002/14651858.CD006036.pub2]

Khan 2010

Khan F, Ng L, Amatya B, Brand C, Turner‐Stokes L. Multidisciplinary care for Guillain‐Barré syndrome. Cochrane Database of Systematic Reviews 2010;10:1‐26. [DOI: 10.1002/14651858.CD008505.pub2]

Khan 2014

Khan F, Amatya B, Drummond K, Galea M. Effectiveness of integrated multidisciplinary rehabilitation in primary brain cancer survivors in an Australian community cohort: a controlled clinical trial. Journal of Rehabilitation Medicine 2014;46(8):754‐60.

Lacasse 2006

Lacasse Y, Goldstein R, Lasserson TJ, Martin S. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews 2006, Issue 4. [DOI: 10.1002/14651858.CD003793.pub2]

Lombardi 2002

Lombardi F, Taricco M, De Tanti A, Telaro E, Liberati A. Sensory stimulation for brain injured individuals in coma or vegetative state. Cochrane Database of Systematic Reviews 2002, Issue 2. [DOI: 10.1002/14651858.CD001427]

Ng 2009

Ng L, Khan F. Multidisciplinary care for adults with amyotrophic lateral sclerosis or motor neuron disease. Cochrane Database of Systematic Reviews 2009, Issue 4. [DOI: 10.1002/14651858.CD007425.pub2]

Prigatano 1994

Prigatano GP, Klonoff PS, O'Brien KP, Altman IM, Amin K, Chiapello D, et al. Productivity after neuropsychologically oriented milieu rehabilitation. Journal of Head Trauma Rehabilitation 1994;9:91‐102.

Roding 2003

Roding J, Lindstrom B, Malm J, Ohman A. Frustrated and invisible ‐ younger stroke patients' experiences of the rehabilitation process. Disability and Rehabilitation 2003;25:867‐74.

Royal College of Physicians 2008

Royal College of Physicians. National Clinical Guidelines for Stroke. Third Edition. National Clinical Guidelines for Stroke. 3rd Edition. London, UK: RCP, 2008.

Shiel 2008

Shiel A, Hawe P, Gold L. Complex interventions or complex systems? Implications for health economic evaluation. British Medical Journal 2008;336:1281‐3.

Steultjens 2003a

Steultjens EMJ, Dekker J, Bouter LM, van Schaardenburg D, van Kuyk MAH, van den Ende CHM. Occupational therapy for rheumatoid arthritis. Cochrane Database of Systematic Reviews 2004, Issue 1. [DOI: 10.1002/14651858.CD003114.pub2]

Steultjens 2003b

Steultjens EMJ, Dekker J, Bouter LM, van de Nes JCM, Cup EHC, van den Ende CHM. Occupational therapy for stroke patients: a systematic review. Stroke 2003;34(3):676‐87.

Tennant 2002

Tennant A. The Rasch Model and standardising outcome in rehabilitation: the PRO‐ESOR project. 13th European Congress in Physical and Rehabilitation Medicine, Brighton. 2002.

Turner‐Stokes 1997

Turner‐Stokes L, Turner‐Stokes T. The use of standardised outcome measures in rehabilitation centres in the UK. Clinical Rehabilitation 1997;11:306‐13.

Turner‐Stokes 2006

Turner‐Stokes L, Paul S, Williams H. Efficiency of specialist rehabilitation in reducing dependency and costs of continuing care for adults with complex acquired brain injuries. Journal of Neurology, Neurosurgery and Psychiatry 2006;77(5):634‐9.

Turner‐Stokes 2007

Turner‐Stokes L. Cost‐efficiency of longer‐stay rehabilitation programmes: can they provide value for money?. Brain injury 2007;21(10):1015‐21.

Turner‐Stokes 2008

Turner‐Stokes L. Evidence for the effectiveness of multi‐disciplinary rehabilitation following acquired brain injury: a synthesis of two systematic approaches. Journal of Rehabilitation Medicine 2008;40(9):691‐701.

Turner‐Stokes 2012

Turner‐Stokes L, Williams H, Sephton K, Rose H, Harris S, Thu A. Engaging the hearts and minds of clinicians in outcome measurement ‐ the UK Rehabilitation Outcomes Collaborative approach. Disability and Rehabilitation 2012;34(22):1871‐9.

Turner‐Stokes 2013

Turner‐Stokes L, McCrone P, Jackson DM, Siegert RJ. The Needs and Provision Complexity Scale: a multicentre prospective cohort analysis of met and unmet needs and their cost implications for patients with complex neurological disability. BMJOpen2013; Vol. 3, issue 2:e002353. [DOI: 10.1136/bmjopen‐2012‐002353]

van Tulder 1997

van Tulder MW, Assendelft WJJ, Koes BW, Bouter LM. Method guidelines for systematic reviews in the Cochrane Collaboration Back Review Group for spinal disorders. Spine 1997;22:2323‐30.

van Tulder 2003

van Tulder M, Furlan A, Bombardier C, Bouter L, The Editorial Board of the Cochrane Collaboration Back Review Group. Updated method guidelines for systematic reviews in the Cochrane Collaboration Back Review Group. Spine 2003;28(12):1290‐9.

Wade 1992

Wade DT. Measurement in Neurological Rehabilitation. Oxford: Oxford University Press, 1992.

Wade 2000

Wade DT, de Jong BA. Recent advances in rehabilitation. BMJ 2000;320:1385‐8.

Wade 2003

Wade DT, Halligan P. New wine in old bottles: the WHO ICF as an explanatory model of human behaviour. Clinical Rehabilitation 2003;17(4):349‐54.

Wade 2004

Wade DT, Halligan P. Do biomedical models of illness make for good healthcare systems?. BMJ 2004;329:1398‐401.

Whyte 2002

Whyte J. Traumatic brain injury rehabilitation: are there alternatives to randomized clinical trials?. Archives of Physical Medicine and Rehabilitation 2002;83(9):1320‐2.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Andelic 2012

Methods

Controlled study

Participants

Severe TBI

Recruited (completed follow‐up) n = 64 (61): early rehabilitation group n = 33 (31); subacute rehabilitation group n = 31 (30)

Interventions

Early rehabilitation in Early Rehabilitation Section of ITU or standard subacute rehabilitation after waiting period at a local hospital or in a nursing home

Outcomes

Glasgow Outcome Scale Extended (GOSE)

Disability Rating Scale (DRS)

Employment status at 12 mo

Home care setup

Notes

Outcome measurement at 12 mo only

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Not an RCT. The trial used availability of a bed in the early rehabilitation unit to assign people to the active or control arms. If a bed was not available, the patient was entered into the control group.

Allocation concealment (selection bias)

High risk

There was no allocation concealment

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Assessors not blinded

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Acceptable attrition. Follow‐up of 61/65 people (95%)

Selective reporting (reporting bias)

Unclear risk

Based on the published report, the results for all primary and secondary outcome measures are available. The review authors did not search for the study protocol. The study report does not give details of a study registration number, and we are unable to check the reporting of outcomes against the study registration details.

Bai 2012

Methods

Single‐blind RCT

Participants

Moderate to severe intracerebral haemorrhage

Randomly assigned n = 364: early rehabilitation group n = 181; control group n = 183

(all completed)

Interventions

Intervention arm received a standardised 6‐mo 3‐stage rehabilitation programme starting on admission

Control arm received standard medical care only

Outcomes

Fugl‐Myer Assessment (FMA)

Modified Barthel Index (MBI)

Notes

Follow‐up: 1, 3 and 6 mo

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Method of randomisation not specified. Quote: "the patients were randomized into two treatment groups" p. 1377

Allocation concealment (selection bias)

Unclear risk

Method of allocation concealment not specified

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Outcome assessors blinded. Quote: "All measurements were recorded by an assessor who was blinded to the study design and details." p. 1376

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Acceptable attrition. Follow‐up of 364/364 people (100%)

Selective reporting (reporting bias)

Unclear risk

Based on the published report, the results for all primary and secondary outcome measures are available. The review authors did not search for the study protocol. The study report does not give details of a study registration number, and we are unable to check the reporting of outcomes against the study registration details.

Björkdahl 2006

Methods

Single‐blind RCT

Participants

Stroke

Randomly assigned (completed) n = 61 (59): home group n = 30 (29); day clinic group n = 29 (29)

Interventions

9 h of training per week for 3 wk

Home group: OT and PT trained patient at home with family

Day clinic group: multi‐professional team trained patient in the day clinic

Outcomes

Assessment of Motor and Process Skills (AMPS)

Functional Independence Measure (FIM)

Instrumental Activity Measure

30‐Metre Walking Test

National Institutes of Health Stroke Scale (NIHSS)

Barrow Neurological Institute screening for higher cerebral functions

Notes

Follow‐up: 3 wk, 3 mo, 1 y

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Method of randomisation not specified. Quote: "...were randomized" p. 1039. Quote: "Information on randomization was kept in storage by the person allocating to the groups until the study was finished." p. 1042

Allocation concealment (selection bias)

Low risk

Quote: "Using sealed envelopes." p. 1039. Authors' judgement: Probably done.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Outcome assessors blinded. Quote: "Blinded assessors made all evaluations at discharge and after the intervention at three weeks as well as at additional follow‐ups at three months and one year after discharge. Blinding was performed by informing the subject not to comment on training (how and where)." p. 1042

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Acceptable attrition. Follow‐up of 59/61 people (96.7%)

Selective reporting (reporting bias)

Unclear risk

Based on the published report, the results for all primary and secondary outcome measures are available. The review authors did not search for the study protocol. The study pre‐dates the requirement of trial registration for publication.

Bowen 2001

Methods

Unblinded controlled trial

Participants

Moderate to severe TBI

Carers n = 96 recruited: treatment group n = 69, control group n = 27
(all completed)

Interventions

Head Injury Neurorehabilitation Team (HINT)
Early = started pre‐discharge
Late = started after discharge
Control = existing services

Outcomes

Carers' perception of how well informed they are
Carers' mood/emotion

Notes

Follow‐up: 6 mo

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Trial used date of admission to allocate to intervention

Van Tulder guidance explicitly cites this as inadequate randomisation. Previous publication scored randomisation as adequate; therefore we have downgraded the van Tulder score.

Quote from the abstract: “Individual randomization was not possible and randomization by hospital site was rejected because of demographic and clinical differences between sites.”

Allocation concealment (selection bias)

Unclear risk

Review authors’ judgement: Unclear if done. Quote from abstract: “Group assignment was determined by a pre‐specified timetable which alternated between hospitals.”

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Assessors not blinded

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Acceptable attrition. Follow‐up of 96/96 people (100%)

Selective reporting (reporting bias)

Unclear risk

Based on the published report, the results for all primary and secondary outcome measures are available. The review authors did not search for the study protocol. The study pre‐dates the requirement of trial registration for publication.

Cicerone 2008

Methods

Single‐blind RCT

Participants

Mild to severe traumatic brain injury

Randomly assigned (completed) n = 68 (64): intensive cognitive rehabilitation group n = 34 (32); standard neurorehabilitation group n = 34 (32)

Interventions

Cognitive group received ‘intensive neuropsychological’ rehabilitation in a day hospital therapeutic environment based on the milieu model described by Ben‐Yishay and Gold, with more group‐based interventions

Standard rehabilitation group was given primarily individual discipline‐specific out‐patient intervention

Outcomes

Community Integration Questionnaire (CIQ)

Perceived Quality of Life Scale (PQOL)

Neuropsychological functioning

Perceived self efficacy score

Vocational Integration Scale

Notes

Outcome measures administered 2 weeks post discharge and at 6 months

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: “Randomization was conducted through the web‐based interactive statistical calculation pages (www.statpages.org) to allocate 48 participants per condition. Randomization occurred in unequal, blocked multiples of 4 to optimize equal assignment of participants to treatment arms throughout the study period and prevent anticipation of the randomization sequence. Randomization was stratified by referral source (clinical or community referrals) to optimize equal assignment between treatment arms….Participants were randomized in the order they provided written informed consent.” p. 2240

Allocation concealment (selection bias)

Low risk

Quote: “The allocation of participants to treatment condition was concealed by placing the individual randomized assignments in sequentially numbered, opaque, sealed envelopes.” p. 2240

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Outcome assessors blinded. Quote: “Data entry and scoring for these measures were conducted by a research assistant who was blind to treatment condition.” p. 2243

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Acceptable attrition. Follow‐up of 64/68 people (94%)

Selective reporting (reporting bias)

Unclear risk

Based on the published report, the results for all primary and secondary outcome measures are available. The review authors did not search for the study protocol. The study pre‐dates the requirement of trial registration for publication.

Elgmark 2007

Methods

Single‐blind RCT

Participants

Mild traumatic brain Injury

Randomly assigned (completed) n = 395 (355): treatment group n = 264 (246); control group n = 131 (109)

Interventions

Follow‐up at 2 to 8 wk by telephone or letter with advice and referral as required

Control = no specific treatment (routine care)

Outcomes

Post‐Concussion Symptom Questionnaire (PCSQ)

Life Satisfaction Questionnaire

Community Integration Questionnaire (CIQ)

Short‐Form Health Survey (SF‐36)

Notes

Participants sent 2 questionnaires, first between 2 and 8 wk post injury, second at 1 y

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Automated randomisation process. Quote: "The patient was allocated to either the intervention group or controls by the automatic randomization procedure using the method introduced by Pocock for optimized allocation. The two groups were balanced according to the following ten variables..." p 153

Allocation concealment (selection bias)

Low risk

Authors' judgement: Based on the quote above, allocation concealment was probably done.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Outcome assessors were adequately blinded. Quote "Blinding of outcome assessment was effected by using mailed questionnaires for self‐rating; the data thus collected were entered by a secretary having no information of the allocation and then send to the statisticians." p 153

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Acceptable attrition. Follow‐up of 355/395 people (89.87%)

Selective reporting (reporting bias)

Unclear risk

Based on the published report, the results for all primary and secondary outcome measures are available. The review authors did not search for the study protocol. The study (1997‐2001) pre‐dates the requirement of trial registration for publication (2005).

Kwakkel 1999

Methods

Single‐blind RCT

Participants

Middle cerebral artery stroke
Randomly assigned (completed) n = 101 (81): leg training group n = 31 (26); arm training group n = 33 (29); control group n = 37 (34)

Interventions

Intensive arm or leg training by physio/occupational therapists vs immobilisation with inflatable splint

Outcomes

Primary outcomes: Barthel ADL Index
Mobility: Functional Ambulation Category (FAC)
Dexterity: Action Research Arm Test
Secondary outcomes: Participation: Sickness Impact Profile (SIP), Nottingham Health Profile (NHP), Frenchay Activities Index

Notes

Follow‐up: 6 mo

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "random number tables for each participating hospital". p 192

Allocation concealment (selection bias)

Low risk

Quote: "random number tables for each participating hospital". p 192

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Participants unblinded after 6 mo, but primary outcomes examined at 6, 9 and 12 mo ‐ therefore, only partially blinded. On the other hand, no significant intergroup differences in the unblinded period, so risk of bias graded as 'unclear'

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Acceptable attrition. Follow‐up of 81/101 people (80%)

Selective reporting (reporting bias)

Unclear risk

Based on the published report, the results for all primary and secondary outcome measures are available. The review authors did not search for the study protocol. The study pre‐dates the requirement of trial registration for publication

Ozdemir 2001

Methods

Controlled study

Participants

Stroke patients n = 60
Recuited n = 60: in‐patient group n = 30; home group n = 30
(all completed)

Interventions

In‐patient rehabilitation vs home exercise programme

Outcomes

Impairment: Ashworth Scale; Brunnstrom stages; Mini‐Mental State Examination (MMSE)
Activity: Functional Independence Measure (FIM)

Notes

Variable measurements before and after rehabilitation (mean 64 d)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Quote: "Sixty patients were randomized into 2 equal groups by selecting patients consecutively, one by one, according to when they enrolled in the study (x+1). Thirty patients in group 1 received intense multidisciplinary rehabilitation services as inpatients in the rehabilitation clinic. The 30 patients in group 2 were given rehabilitation services in their own homes. p. 1376

Allocation concealment (selection bias)

High risk

Authors' judgement: no indication that the allocation method was concealed

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Blinding of outcome assessors not specified. Authors' judgement: Probably not done. Participants receiving inpatient rehabilitation were assessed at the hospital, while those receiving rehabilitation at home were assessed at home.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Acceptable attrition. Follow‐up of 60/60 people (100%)

Selective reporting (reporting bias)

Unclear risk

Based on the published report, the results for all primary and secondary outcome measures are available. The review authors did not search for the study protocol. The study pre‐dates the requirement of trial registration for publication

Paniak 1998

Methods

Single‐blind RCT

Participants

Moderate to severe TBI
Randomly assigned (completed) n = 119 (111): treatment group n = 53 (59); control group n = 58 (60)

Interventions

Treatment as needed with full MD programme vs single session ‐ educational input

Outcomes

Impairment: Problem checklist
Participation: Community Integration Questionnaire (CIQ)

Health status: Short‐Form Health Survey (SF‐36)
Work status

Notes

Follow‐up: 3 to 4 mo

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Method of randomisation not specified. Paper previously scored as having adequate randomisation; therefore, we have downgraded the van Tulder score

Quote: "Patients were randomly assigned..." p. 1013

Allocation concealment (selection bias)

Unclear risk

Method of allocation concealment not specified

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Van Tulder scoring explicitly states that when patient‐reported outcome measures are used, the trial cannot be positively scored for blinding for outcome assessment. Paper previously graded as adequate so we have downgraded the van Tulder score, but risk of bias remains unclear

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Acceptable attrition. Follow‐up of 111/119 people (93%)

Selective reporting (reporting bias)

Unclear risk

Based on the published report, the results for all primary and secondary outcome measures are available. The review authors did not search for the study protocol. The study pre‐dates the requirement of trial registration for publication

Powell 2002

Methods

Single‐blind RCT

Participants

Moderate to severe TBI
Randomly assigned (completed) n = 110 (94): treatment group n = 54 (48); control group n = 56 (46)

Interventions

Community‐based outreach MD team
Visits × 2/wk. Mean 6 mo in duration
Control ‐ written information only

Outcomes

Activity: Barthel Index; Functional Assessment Measure (FIM+FAM)
Participation: Brain Injury Comunity Rehabilitation Outcome scales (BICRO‐39)
Mood: Hospital Anxiety and Depression Scale (HADS)
Maximum Gain Index (MGI)

Notes

Variable measurement (mean 2 y)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

There was no randomisation sequence. Quote: "Randomisation was conducted on an individual basis. Information/outreach codes (I and O) were written onto squares of paper, in equal proportion, and these were placed in a sealed, opaque envelope. This was prepared and held by the clinical director of the team. Once a participant's eligibility and agreement to participate had been established, one of the codes was drawn at random from the envelope by a therapist or other staff member who had not been involved in the patient's assignment, and it was then discarded and the envelope resealed." p. 194

Allocation concealment (selection bias)

Unclear risk

All squares were put into one sealed envelope, and drawn one at a time.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Although blinding was reportedly broken in some cases, this potentially applies to all single‐blinded studies, whether or not this is openly recognised by study authors. Quote: "the independent follow up assessor was not informed of participants' allocation codes at any stage throughout data collection or data entry; the codes were entered only when the database was complete." p. 194

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Acceptable attrition. Follow‐up of 94/110 people (85%)

Selective reporting (reporting bias)

Low risk

Based on the published report, the results for all primary and secondary outcome measures are available. The review authors did not search for the study protocol. The study pre‐dates the requirement of trial registration for publication

Salazar 2000

Methods

Unblinded RCT

Participants

Defence veterans moderate to severe TBI
Randomly assigned (completed) n = 120 (107); in‐patient n = 67 (60); home n = 53 (47)

Interventions

In‐patient: intensive 8‐wk programme vs
Home: weekly telephone contact with counselling and advice from nurse

Outcomes

Work status: return to work
Fitness for military duty

Notes

Follow‐up: 1 y

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Randomization for the first 40 participants was weighted at a 2:1 ratio in favor of the in‐hospital group to help build that program. The last 79 patients enrolled were randomized at a 1:1 ratio. Analysis of outcomes stratified for these 2 cohorts did not change results." p. 3076

Allocation concealment (selection bias)

Low risk

Quote: "Blocked randomization was done by an independent study statistician (K.S.) using variable‐sized blocks to prevent investigators from guessing the code." p. 3076

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Not blinded

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Acceptable attrition. Follow‐up of 107/120 people (89%)

Selective reporting (reporting bias)

Low risk

Based on the published report, the results for all primary and secondary outcome measures are available. The review authors did not search for the study protocol. The study pre‐dates the requirement of trial registration for publication

Semlyen 1998

Methods

Unblinded controlled study

Participants

Patients with moderate to severe n = 51
Total n = 51: treatment group n = 33, control group n = 18
(all completed)

Interventions

Co‐ordinated MD rehabilitation on a specialist brain injury rehabilitation unit (HM) vs other rehabilitation (OR) in local district services

Outcomes

Activity and independence: Barthel Index
Functional Assessment Measure (FIM+FAM)
Newcastle Independence Assesment Form (NIAF)
Care‐giver's health: General Health Questionnaire (GHQ‐28)

Notes

Follow‐up: to 2 y

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

There was no randomisation sequence. Quote: "Two groups of patients were selected using the same set of inclusion criteria. All individuals received initial management in the Regional Neurosciences Centre at Newcastle General Hospital. When the neurosurgical team considered the individual ready for transfer, the patient was either set to Hunters Moor Regional Rehabilitation Centre or to a local hospital. This selection process was based partly on geography (the further the patient lived away from Newcastle the more likely they were to be sent back to a local hospital near home) and partly on bed availability at Hunters Moor. (If a bed was not available within a few days the patient was more likely to be sent to the local hospital.) One group received a coordinated, multidisciplinary rehabilitation service at Hunters Moor." p. 679

Allocation concealment (selection bias)

High risk

Not done

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Unblinded

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition acceptable. Follow up of 51/51 people (100%)

Selective reporting (reporting bias)

Low risk

Based on the published report, the results for all primary and secondary outcome measures are available. The review authors did not search for the study protocol. The study pre‐dates the requirement of trial registration for publication

Shiel 2001

Methods

Unblinded RCT

Participants

Patients with moderate to severe TBI n = 51
Randomly assigned n = 51: intensive rehabilitation group n = 24; routine group n = 27
(all completed)

Interventions

Intensive rehabilitation (with additional healthcare professional experienced in BI) vs standard treatment

Outcomes

Disability: Functional Assessment Measure (FIM+FAM)
Healthcare: length of stay

Notes

Admission to discharge

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "The research unit experimental officer (MEB), who was otherwise uninvolved in the research, implemented the randomization using a computer package. Age, centre and severity of injury, judged on the basis of the GCS, were used to stratify the allocation. In order to match groups as equally as possible, random permuted bocks within strata were used. ... Subjects were recruited by the researchers based at each centre who telephoned details of the injury severity, centre and age to the experimental officer who then gave the treatment allocation." p. 503

Allocation concealment (selection bias)

Low risk

Van Tulder guidance requires that those allocating have no knowledge of participant characteristics for allocation concealment to be scored positively. Complex reallocation process performed to equalise groups in this study relied on some knowledge of participant characteristics. Therefore, it was scored negatively on van Tulder – this nevertheless poses low risk of bias, as the adjustment was made to correct failure of randomisation in relation to severity

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "Outcome measurement at discharge and one year after injury was done by a masked assessor and the codes were only broken when all one year assessments were complete." p. 503

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Acceptable attrition. Follow‐up of 51/51 people (100%)

Selective reporting (reporting bias)

Unclear risk

Based on the published report, the results for all primary and secondary outcome measures are available. The review authors did not search for the study protocol. The study pre‐dates the requirement of trial registration for publication

Slade 2002

Methods

Single‐blind RCT

Participants

Mixed brain injury (moderate to severe) and stroke

Randomly assigned (completed) n = 161 (131): intensive group n = 80 (75); standard treatment group n = 81 (76)

Interventions

Intensive MD rehabilitation: intensive group received 67% more therapy

Outcomes

Healthcare: length of stay: controlled for ADL ability; Barthel Index

Notes

Admission to discharge

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Randomisation occurred when the admission date of the patient was known, in order to allow for the timetabling of therapy, usually undertaken a week in advance. Patients were randomised to experimental and control groups by the university epidemiological unit. Randomisations used successive blocks of 8 or 12. This prevented unequal group sizes, so that in a block of 8 forinstance there would be 4 randomisations in the experimental group and 4 in the control group in any combination e.g. eeccecec or ccceecee. The blocks were of different sizes to prevent anticipation by staff on group randomisation. Runs of control or experimental randomisations were limited to four, to ensure intensive therapy could be delivered." p 34

Allocation concealment (selection bias)

High risk

Allocation concealment inadequate; van Tulder re‐scored to reflect this

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Participants and team members blinded to participant grouping. Unclear how successful this blinding was – some team members did know. Van Tulder rating also re‐scored to reflect this

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Acceptable attrition. Follow‐up of 131/161 people (81%)

Selective reporting (reporting bias)

Unclear risk

Based on the published report, the results for all primary and secondary outcome measures are available. The review authors did not search for the study protocol. The study pre‐dates the requirement of trial registration for publication

Smith 1981

Methods

Unblinded RCT

Participants

Stroke patients discharged from hospital
Total randomly assigned n = 133: intensive treatment group n = 46; conventional treatment group n = 43; control group n = 44
(all completed)

Interventions

Out‐patient physiotherapy/occupational therapy for up to 6 mo
Intensive = 4 d/wk
Conventional = 3 half‐days/wk
Control = health visitor encourages self exercise

Outcomes

ADL dependency: Northwick Park ADL Index

Notes

Follow‐up: at 3 and 12 months

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Adequate randomisation; author communication

Allocation concealment (selection bias)

Low risk

Adequate allocation concealment; author communication

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Blinded

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition rate acceptable

Selective reporting (reporting bias)

Low risk

Results for all primary and secondary outcome measures reported

Wade 1997

Methods

Single‐blind RCT

Participants

TBI ‐ all severities (presenting via A&E)

Randomly assigned (completed) n = 1156 (478): treatment group n = 579 (252); control group n = 577 (226)

Interventions

Oxford Head Injury Service (OxHIS)
Advice and referral as required
Control: standard services only

Outcomes

Symptoms: Post concussion: Rivermead Post‐concussion symptoms Questionnaire (RPQ)
Social disability: Rivermead Follow‐Up Questionnaire (RHFUQ); post‐traumatic amnesia

Notes

6 months

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "...of whom 1156 were randomised into two equal groups, using a list of computer generated random numbers..." p. 479

Allocation concealment (selection bias)

Low risk

Allocation concealment acceptable ‐ study author communication

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "At six months after injury, all randomised patients were approached by one of two clinicians who had not been involved in the early follow up service, and who remained unaware to which group patients had been assigned." p. 479

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition acceptable given study design. Follow‐up of 478/1156 people (41%)

Selective reporting (reporting bias)

Unclear risk

Based on the published report, the results for all primary and secondary outcome measures are available. The review authors did not search for the study protocol. The study pre‐dates the requirement of trial registration for publication

Wade 1998

Methods

Single‐blind RCT

Participants

TBI ‐ all severities (but only if admitted to hospital)
Randomly assigned (completed) n = 321 (218)
Treatment n = 184 (132); control n = 130 (86)

Interventions

Oxford Head Injury Service (OxHIS)
Advice and referral as required
Control: standard services only

Outcomes

Symptoms: Post concussion: Rivermead Post‐concussion symptoms Questionnaire (RPQ)
Social disability: Rivermead Follow‐Up Questionnaire (RHFUQ); post‐traumatic amnesia

Notes

6 mo

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated random numbers

Allocation concealment (selection bias)

Low risk

Allocation concealment adequate ‐ study author communication

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Outcome assessors adequately blinded

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition acceptable given design ‐ study author communication

Selective reporting (reporting bias)

Low risk

Results for all primary and secondary outcome measures reported

Werner 1996

Methods

Single‐blind RCT

Participants

Stroke patients ‐ ≥ 1 y since stroke (mean 2.9 y)
Randomly assigned (completed) n = 49 (35): treatment group n = 33 (28); control group n = 16 (7)
(5 additional non‐randomised controls recruited)

Interventions

Late treatment:
Out‐patient physio/OT for 3 mo vs no treatment

Outcomes

Activity: Functional Independence Measure ‐ Motor subscale (FIM‐Motor)
Restriction of participation: Sickness Impact Profile (SIP)
Mood: Beck Depression Inventory (BDI)

Notes

Follow‐up: at 3 and 9 mo

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random numbers table used

Allocation concealment (selection bias)

High risk

Inadequate concealment

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Outcome assessors adequately blinded

Incomplete outcome data (attrition bias)
All outcomes

High risk

Attrition rate unacceptably high

Selective reporting (reporting bias)

Low risk

Results for all primary and secondary outcome measures reported

Zhu 2007

Methods

Single‐blind RCT

Participants

Moderate to severe TBI

Randomly assigned n = 68: intensive group n = 36; conventional treatment n = 32

(all completed)

Interventions

Multi‐disciplinary rehabilitation at 2 intensities:

Intensive: 4 h/d, 5 d/wk

Conventional: 2 h/d, 5 d/wk

Outcomes

Global outcome: Glasgow Outcome Scale (GOS)

Activity (disability): Functional Independence Measure (FIM)

Neurobehavioural Cognitive Status Examination (NCSE)

Notes

Assessment points: 0, 1, 2, 3, 4, 5, 8, 10, and 12 mo

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "The patients were then randomly assigned to intensive or control groups using stratified blocked randomization. The patients were first stratified according to the severity of the brain injury (moderate or severe) and then pooled into groups of 10. Randomization was conducted separately for each of the moderate‐to‐severe sub‐groups by drawing one of several double‐sealed envelopes. The number of envelopes assigned to the intensive or conventional groups in each randomization was kept as equal as possible. The randomizations were conducted by a research assistant who was not involved in the clinical management. The patients, along with the sealed envelopes, were then transferred to the rehabilitation hospital where the rehabilitation programme was carried out. All patients were assessed by the same multi‐disciplinary rehabilitation team before the treatment protocol assignment, as indicated in the sealed envelope, was revealed." p. 683

Allocation concealment (selection bias)

Low risk

Quote: "Double‐sealed envelopes". Authors' judgement: Probably done.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "All assessments were conducted in the acute hospital by personnel who were not involved in the randomization and who did not provide the rehabilitation training." p. 684

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Acceptable attrition. Follow‐up of 35/49 people (71%)

Selective reporting (reporting bias)

Unclear risk

Based on the published report, the results for all primary and secondary outcome measures are available. The review authors did not search for the study protocol. The study pre‐dates the requirement of trial registration for publication

Abbreviations:

ADLs = activities of daily living.

AMPS = Assessment of Motor and Process Skills.

BI = Brain Injury.

DRS = Disability Rating Score.

FIM = Functional Independence Measure.

FMA = Fugl‐Meyer Assessment.

GHQ‐28 = General Health Questionnaire 28.

GOSE = Glasgow Outcome Scale Extended.

HINT = Head Injury Neurorehabilitation Team.

ICU = Intensive Care Unit.

MBI = Modified Barthel Index.

MD = multi‐disciplinary.

NCSE = Neurobehavioural Cognitive Status Examination.

NIAF = Newcastle Independent Assessment Form.

NIHSS = National Institutes of Health Stroke Scale.

OT = occupational therapy.

PT = physiotherapy.

RCT = randomised controlled trial.

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Bjorkdahl 2007

Fatally flawed: small numbers with high chance of type II error and poorly matched groups at baseline

Browne 2013

Fatally flawed: poor matching of groups at baseline (lack of functional outcome measures), significantly large attrition rate of 30% and very low quality as per van Tulder criteria

Ownsworth 2008

Fatally flawed: very small numbers with high chance of type II error, and, importantly, no evidence of outcome comparisons between intervention and control groups, which in this case included those on a waitlist

Relander 1972

Fatally flawed: > 40% attrition at 1‐y follow‐up. Outcome measured by questionnaire only, with no validating evidence presented

Sonoda 2004

Low methodological quality as per van Tulder criteria

Vanderploeg 2008

Does not identify a clearly hypothesised intervention and control, so does not fit our pre‐defined criteria

Characteristics of ongoing studies [ordered by study ID]

NCT00869154

Trial name or title

Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury

Methods

Randomised controlled trial

Participants

People with a traumatic brain injury with brief loss of consciousness, age 16‐55

Interventions

Intervention: Multidisciplinary care follow‐up
Control: Primary care follow‐up

Outcomes

Primary outcome: Return to work.
Secondary outcomes:
1. Glasgow Outcome Scale Extended score
2. The Rivermead Post concussion symptoms questionnaire score
3. Patient's Global Impression of Change

Starting date

March 2009

Contact information

Haukeland University Hospital, Bergen, Norway
Jan Sture Skouen, MD, PhD

Notes

Study flow diagram. The numbers for identification, screening and eligibility are from updated searches in 2013, 2014 and 2015.
Figuras y tablas -
Figure 1

Study flow diagram. The numbers for identification, screening and eligibility are from updated searches in 2013, 2014 and 2015.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies. Nineteen studies are included in this review.
Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies. Nineteen studies are included in this review.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Table 1. Scoring criteria based on the method of van Tulder (1997)

Criterion

Score positive if:

Eligibility criteria specified

A list of inclusion/exclusion criteria was explicitly stated.

Method of randomisation

A random (unpredictable) assignment sequence was used.

Treatment allocation concealment

Assignment was concealed from investigators. Assignment was generated by an independent person not responsible for determining the eligibility of patients. This person has no information about individuals included in the trial and has no influence on the assignment sequence nor on the decision about eligibility of patients.

Similarity of baseline characteristics

Study groups were comparable at baseline for important prognostic parameters. To receive a 'yes', groups had to be similar at baseline regarding demographic factors, duration and severity of complaints, percentage of patients with neurological symptoms and value of main outcome measure(s).

Treatment and control interventions specifically described

Details are given of the programme, including disciplines involved and treatment duration.

Care provider blinded to the intervention

Treating team is blinded regarding the intervention (NB: rarely possible in this context).

Co‐interventions avoided or equal

Co‐interventions should be avoided in the trial design or similar between index and control.

Compliance

Compliance was measured and satisfactory in all study groups.

Participant blinded to the intervention

Participant was blinded regarding the intervention (NB: rarely possible in this context if consent procedures are properly applied).

Outcome assessor blinded to the intervention

Outcome assessor was blinded regarding treatment allocation, and standardised assessment measures were used to structure the interviews. Scored negative if only self reported (questionnaire) outcomes were used and no observer outcomes were provided.

Outcome measures relevant

Outcome measures reflected disability (activity) or participation as relevant to the intervention.

Adverse effects described

Any adverse effects of the intervention are described.

Withdrawal rate described and acceptable

Number of participants included in the study who did not complete the observation period or were not included in the analysis must be described and reasons given. If percentage of withdrawals and dropouts does not exceed 20% for immediate‐ and short‐term follow‐up or 30% for intermediate‐ and long‐term follow‐up, and does not lead to substantial bias, 'yes' is scored.

Short‐term outcome measurement

Outcomes were measured at the end of treatment (e.g. admission to discharge) or within 6 months of the end of treatment.

Long‐term outcome measurement

Outcomes were measured at 1 year or longer.

Timing of outcome assessment in both groups comparable

Timing of outcome assessment should be identical for all intervention groups and for all important outcome assessments.

Sample size described for each group

Number of participants was stated for each group.

Intention‐to‐treat analysis

All randomly assigned participants were included in the analysis (minus missing values), irrespective of non‐compliance and co‐interventions. If loss to follow‐up was substantial (≥ 20%), an intention‐to‐treat analysis as well as an alternative analysis that accounts for missing values (e.g. a worst‐case analysis) should have been performed.

Point estimates and measures of variability

A mean or median figure was given for each important outcome parameter, together with a measure of variability such as standard deviation, standard error of the mean or 95% confidence intervals.

Figuras y tablas -
Table 1. Scoring criteria based on the method of van Tulder (1997)
Table 2. Methodological quality as assessed by the van Tulder method

Category of evidence

Criteria

Strong evidence

Consistent statistically significant findings in outcome measures in ≥ 2 high‐quality RCTs.

Moderate evidence

Consistent statistically significant findings in outcome measures in ≥ 1 high‐quality RCT and ≥ 1 controlled study.

Limited evidence

Consistent statistically significant findings in outcome measures in ≥ 1 high‐quality RCT, or
Consistent statistically significant findings in outcome measures in ≥ 2 controlled studies.

Indicative findings

Consistent statistically significant findings in process or outcome measures in ≥ 1 controlled studies.

No evidence

Conflicting results between trials or in cases of insufficient data.

Figuras y tablas -
Table 2. Methodological quality as assessed by the van Tulder method
Table 3. Methodological quality as assessed by the van Tulder method

Study ID

Internal validity

Descriptive criteria

Statistical criteria

Total score

Positive criteria

Kwakkel 1999

8

5

2

15

a,bi,bii,c,d,f,g,j,l,mi,mii,n,o,p,q.

Wade 1997

8

4

2

14

a,bi,bii,c,d,f,g,i,j,l,mi,n,o,q.

Wade 1998

8

4

2

14

a,bi,bii,c,d,f,g,i,j,l,mi,n,o,q.

Powell 2002

8

4

2

14

a,bi,bii,c,d,f,g,i,j,l,mii,n,o,q.

Cicerone 2008

8

4

2

14

a,bi,bii,c,d,g,i,j,l,mi,n,o,p,q

Smith 1982

7

5

2

14

a,bi,c,d,f,g,i,j,l,mi,mii,n,o.

Salazar 2000

7

5

2

14

a,bi,c,d,f,g,j,l,mi,mii,n,o,p,q.

Paniak 1998

6

5

2

13

a,c,d,f,g,j,l,mi,mii,n,o,p,q.

Slade 2002

7

3

2

12

a,bi,bii,c,d,f,g,j,l,mi,o,p,q

Shiel 2001

7

3

2

12

a,bi,d,g,h,i,j,l,mi,o,q.

Zhu 2007

6

4

2

12

a.bi,bii,c,d,i,j,l,mi,mii,n,o,p,q

Elgmark 2007

6

4

2

12

a,bi,bii,c,d,i,j,l,mii,n,o,p,q

Bowen 2001

4

4

2

10

a,c,d,f,j,l,mi,n,o,p,q.

Bjorkdahl 2006

5

3

2

10

d,i,j,l,mi,mii,n,o,p,q

Bai 2012

5

3

1

9

a,c,g,i,j,l,mi,n,o

Werner 1996

4

4

1

9

a,bi,d,i,j,mi,mii,n,o.

Semlyen 1998

4

4

1

9

a,d,f,g,j,l,mi,mii,n,o.

Andelic 2012

4

4

1

9

a,c,d,g,j,l,mii,n,o

Ozdemir 2001

3

4

2

9

a,c,d,f,g,j,mi,o,q.

Figuras y tablas -
Table 3. Methodological quality as assessed by the van Tulder method
Table 4. Results from the four studies predominantly addressing the milder ambulatory group

Paniak 1998 and 2000

Participant and group comparisons

Patients with TBI admitted to hospital (all severities); mean age 33 y

Intervention: ‘treatment as needed’ (TAN) (n = 58)

Control: single session (SS) of education and advice (n = 53)

Primary outcomes

Impairment: Problem Checklist (PCL)

Participation: Community Integration Questionnaire (CIQ)

Health status: Short‐Form 36 (SF‐36)

Work status: socio‐economic status (SES)

Assessment points

3 to 4 months (n = 111) and 1 year (n = 105)

Summary of results

Participation (CIQ) did not change significantly for either group

Impairment (PCL) and health status (SF‐36): Repeated measures MANOVA showed significant effects for time in both groups, which were maintained at 1 year

Results showed no significant group interaction or time by group for any of the primary outcomes at either time point

Vocational status

(SES)

Intervention

Mean (SD)

Control

Mean (SD)

Difference in mean

P value

(MANOVA)

Pre‐injury

37.2 (18.7)

34.3 (18.5)

2.9

N/S

Baseline

26.9 (20.7)

23.2 (19.9)

0.8

N/S

3 to 4 mo

32.5 (20.2)

32.8 (19.7)

0.3

N/S

1 y

34.8 (19.7)

36.7 (21.0)

1.9

N/S

Authors' conclusions

 

Interventions appear to be equally effective

Salazar 2000

Participant and group comparisons

Active duty military personnel with moderate to severe TBI; mean age 25 y

Intervention: 8‐week intensive in‐patient cognitive‐behavioural programme (n = 67)

Control: limited home programme of weekly telephone support from psychiatric nurse (educational material, counselling and suggested home exercises) (n = 53)

Primary outcomes

Work status: return to work

                       return to fitness for military duty

Assessment points

1 year

Summary of results

No overall differences in outcomes between groups

Post hoc analysis demonstrated significant group interaction (in favour of the intervention group) for ‘fitness for military duty’ at 1 year for the more severe subgroup, who were unconscious for > 1 h

Vocational status at

1 y

Intervention

% achieved

Control

% achieved

Difference

P value

(Fisher's exact)

Return to work

90%

94%

4% (‐5.14)

N/S

Fit for military duty

73%

66%

7% (‐10.24)

N/S

Post hoc analysis of subgroup unconscious for > 1 h (n = 75)

 

(n = 35)

(n = 40)

Difference

P value

Fit for military duty

80%

58%

22%

0.05

Authors' conclusions

Overall benefit of in‐patient cognitive rehabilitation programme similar to that of limited home rehabilitation, although institutional therapy may be beneficial for selected patients with severe TBI

Wade

1997

Participant and group comparisons

All patients presenting to Accident and Emergency following TBI; age 16 to 65 y

Intervention: telephone follow‐up at 7 to 10 days with advice and referral as required (n = 252)

Control: no specific intervention (standard services only) (n = 226)

(NB: Despite major efforts to trace and contact patients, follow‐up interview at 6 months could be achieved in only 478 of 1156 (41%) participants randomly assigned)

Primary outcomes

Social disability: Rivermead Head Injury Follow‐Up Questionnaire (RFUQ)

Symptoms: Rivermead Post‐concussion Symptoms Questionnaire (RPQ)

Assessment points

6 months

Summary of results

No overall differences between intervention and control groups

Post hoc analysis revealed significant group interaction (in favour of the active intervention group) with respect to social disability in a subgroup of individuals with more severe injury (>1 h PTA)

Health status

at 6 mo

Intervention

Mean  (SD)

Control

Mean (SD)

P value

(Mann‐Whitney)

RFUQ

3.6 (6.0)

3.3 (6.3)

N/S

RPQ

7.7 (10.9)

6.8 (10.0)

N/S

Post hoc analysis of subgroup with PTA  > 1 h (n = 121)

(n = 71)

(n = 53)

RFUQ

0.85 (0.89)

1.17 (1.07)

0.003

RPQ

2.03 (0.85)

2.21 (0.89)

N/S

Authors' conclusions

Routine follow‐up does not appear to be necessary for all patients presenting with head injury, but a subgroup of patients with more severe TBI may benefit from such intervention

Wade

1998

Participant and group comparisons

All patients admitted to hospital following TBI (i.e. a more severe group than the total group reported in Wade 1997); age 16 to 65 y

Intervention: telephone follow‐up at 7 to 10 days with advice and referral as required (n = 132)

Control: no specific intervention (standard services only) (n = 86)

(NB: follow‐up data obtained in 218 (69%) of 314 participants randomly assigned)

Primary outcomes

Social disability: Rivermead Head Injury Follow‐Up Questionnaire (RFUQ)

Symptoms: Rivermead Post‐concussion Symptoms Questionnaire (RPQ)

Assessment points

6 months

Summary of results

Significant group interaction (in favour of the active intervention group) with respect to social disability and post‐concussion symptoms. Subgroup analysis demonstrated that the main benefit appeared in the group with PTA < 7 days

Health status

at 6 mo

Intervention

Mean  (SD)

Control

Mean (SD)

P value

(Mann‐Whitney U test)

RFUQ

5.36 (7.81)

8.23 (8.75)

0.01

RPQ

9.8 (11.7)

13.9 (13.6)

0.02

Authors’ conclusions

Early intervention by a specialist service significantly reduced social morbidity and severity of post‐concussion symptoms 6 months after head injury, in the group of patients who required admission to hospital. Possibly most beneficial for the moderate to severe group, some of whom may not present without pro‐active intervention

Elgmark 2007

Participant and group comparisons

All patients aged 16 to 60 with mild traumatic brain injury according to American Congress of Rehabilitation medicine criteria

Intervention: follow‐up at 2 to 8 weeks by telephone or letter with advice and referral as required (n = 264 ‐ 96 received intervention; 150 declined); 18 lost to follow‐up

Control: no specific intervention (regular care) (n = 131); 22 lost to follow‐up

246 treatment and 109 control included in intention‐to‐treat analysis

Primary outcomes

Symptoms: change in post‐concussion symptoms ‐ Swedish Post‐concussion Symptoms Questionnaire (PCSQ)

Social disability: Community Integration Questionnaire (CIQ), Life Satisfaction Questionnaire, Short‐Form Health Survey (SF‐36)

Assessment points

1 y post injury

Summary of results

No statistically significant differences were found between intervention and control groups. Participants who experienced few PCS 2 to 8 weeks post injury declined rehabilitation and returned to work. Those who suffered several PCS and accepted rehabilitation did not recover after 1 y

Health status

at 6 mo

Intervention

Mean (SD)

Control

Mean (SD)

Significance

 

Total PCSQ

5.2 (5.3)

4.4 (5.3)

N/S

CIQ

20.3 (4.0)

19.8 (4.0)

0.02

Authors’ conclusions

In this particular study of MTBI, active rehabilitation did not change outcomes to a significant degree. Additional studies should focus on patients who remain symptomatic during the first 1 to 3 months and should test various types of interventions

PTA = post‐traumatic amnesia; TBI = traumatic brain injury.

Figuras y tablas -
Table 4. Results from the four studies predominantly addressing the milder ambulatory group
Table 5. Results from the two studies addressing out‐patient rehabilitation

Smith

1981

Participant and

group comparisons

Patients suitable for out‐patient rehabilitation following discharge from hospital after acute stroke (n = 133); mean age 63 y

Intervention: out‐patient physiotherapy and occupational therapy for 6 months at 2 levels of intensity:

  • Intensive (4 whole days per week) (n = 46) or

  • Conventional (3 half‐days per week) (n = 43) vs

Control: no routine rehabilitation, health visitor encourages home exercises as learned in hospital (n = 44)

Primary outcomes

Dependency for ADL: Northwick Park ADL score

Assessment points

3 and 12 months

Summary of results

Significantly greater decrease in ADL scores in intNervention groups compared with controls at 3 months. Difference is sustained at 1 y follow‐up with greater number of control group participants

(NB: trend towards better results from intensive rehabilitation than from conventional regimen not tested statistically)

Decrease in ADL score

Intensive rehabilitation

Conventional rehabilitation

Control

P value

Mean change 0 to 3 m

3.54  (n = 41)

2.87 (n = 40)

1.50 (n = 42)

1 vs 3: P value < 0.01

1/2 vs 3: P value < 0.01

Mean change 0 to 12 m

3.50 (n = 36)

2.89 (n = 36)

0.60 (n = 35)

1 vs 3: P value < 0.05

Authors’ conclusions

Out‐patient rehabilitation following stroke appears to be effective. Decreasing intensity of rehabilitation was associated with an increase in both the proportion of participants who deteriorated and the extent to which they deteriorated

Werner 1996

Participant and

group comparisons

Patients discharged from in‐patient rehabilitation and ≥ 1 y (mean 2.9 y) after stroke (n = 49); mean age 63 y

Intervention: out‐patient physiotherapy and occupational therapy (2 hours, 4 times per week, for 3 months) (n = 33)

Control: no specific intervention (n = 16)

(NB: 28% (5/33 intervention group and 9/16 control group) did not complete follow‐up: 5 non‐randomised controls were subsequently recruited to make control numbers up to 12)

Primary outcomes

Activity: Functional Independence Measure ‐ Motor (FIM‐MM)

Limitation of participation: Sickness Impact Profile (SIP)

Depression: Beck Depression Inventory (BDI)

Assessment points

3 and 9 months

Summary of results

Significant changes in FIM and SIP at 3 months maintained at 9 months. Trend towards improved mood did not reach significance

Mean change in score

Intervention

(n = 28)

Control

(n = 12)

Difference in mean

P value

(t‐tests)

FIM‐MM (0 to 3 mo)

6.6

1.5

5.1

0.03

FIM‐MM (3 to 9 mo)

0.7

‐1.0

1.7

N/S

SIP (0 to 3 mo)

‐5.2

2.6

7.8

0.04

BDI (0 to 3 mo)

‐2.6

0.2

2.8

N/S

BDI (3 to 9 mo)

0.7

0.5

0.2

N/S

Authors’ conclusions

Significant gains can still be attained in the post‐acute stroke survivor, despite prior in‐patient rehabilitation services

ADLs = activities of daily living.

Figuras y tablas -
Table 5. Results from the two studies addressing out‐patient rehabilitation
Table 6. Results from the three studies addressing community team‐based rehabilitation

Powell 2002

Participant and

group comparisons

Patients (16 to 65 y) with severe traumatic brain injury 3 mo to 20 y previously (n = 110 allocated: 94 (85%) completed follow‐up)

Intervention: inter‐disciplinary team interventions: 2 sessions per week for mean 27.3 (SD 19.1) weeks in community settings (home, work or day centres) (n = 48)

Control: written information only (n = 46)

Primary outcomes

Activity: Barthel Index (BI)

Participation: Brain Injury Community Rehabilitation Outcome (BICRO‐39)

Assessment points

Approximately 2 y (median 23 mo) (IQR 18 to 40)

Summary of results

Intervention group made significantly greater gains on both BI and BICRO scales. Median changes were small, reflecting the diversity of the population, but 40% of intervention group and only 20% of controls made a clinically significant improvement of 2+ points on ≥ 1 BICRO subscale

Change scores from baseline

Intervention

Control

P value

BI: % improving

Median (IQR) change

35.4%

0 (‐5, 5)

19.6%

0 (‐5, 4)

< 0.05

BICRO‐39: %

Median (IQR) change

80%

2.5 (‐1.7, 6.2)

70%

0.9 (‐4.1, 6.8)

< 0.05

Authors’ conclusions

Multi‐disciplinary community rehabilitation, even years after injury, can make clinically significant gains which outlive the active treatment period.

Bowen

2001

Participant and

group comparisons

Carers of young adult (16 to 65 y) TBI survivors with hospital stay ≥ 3 days (n = 96)

Intervention: active intervention from Head Injury Neurorehabilitation Team (HINT)

  • Early intervention ‐ whilst still in hospital (n = 41)

  • Late intervention ‐ after discharge from hospital (n = 28)

Control: no specific intervention ‐ existing services only (n = 27)

(NB: 20/96 (21%) received service other than that allocated ‐ only 56% allocated to early intervention actually received it)

Primary outcomes

Information received: carer perceptions of how well informed they are ‐ 7 questions

Emotional state: Wimbledon Self‐report Scale (WSS)

Assessment points

6 mo post injury

Summary of results

Analyses adjusted for potential confounding factors confirmed a clinically plausible superior outcome for both treatment groups compared with controls, but none of the results reached significance (set at P value < 0.01)

Mean change  from baseline

Early

(n = 41)

Late

(n = 28)

Control

(n = 27)

P value

(t‐tests)

% poorly informed

46%‐64%

46%‐81%

63%‐89%

N/S

WSS, median (IQR)

3 (0‐9)

2 (0‐6)

8 (1‐15)

N/S

Authors' conclusions

Hypothesis not confirmed, but absence of effect cannot be proven with these data, which may reflect type II error in view of mixing of groups. Longer‐term follow‐up data also required

Bjorkdahl 2006

Participant and

group comparisons

Stroke patients (mean age 53 y) discharged from an in‐patient rehabilitation programme

  • Intervention 1: short programme (3 wk) of home‐based rehabilitation programme, individually tailored, focussed on activities within their natural context (n = 30)

  • Control: programme of similar length in 'ordinary' day clinic rehabilitation (n = 29)

Primary outcomes

Functional assessment:  Motor and Process Skills (AMPS); secondary measures: mobility (30 m walking test); FIM, instrumental activity measure

Impairment: NIH scale

Assessment points

End of intervention (3 wk post discharge), 3 and 12 mo

Summary of results

Both groups improved significantly from discharge to 1‐y follow‐up. No significant differences between groups for any of the 4 assessments, at any time point, although trends show earlier gains in the home‐rehabilitation group. Only the day clinic group changed ‘significantly’ on the FIM, but degree of change was small (5 FIM points over 1 y). Costs of home rehabilitation programme were less than half those of the day clinic

Rasch transformed AMPS data (logits)

Home (n = 30)

Mean (SD)

Day clinic (n = 39)

Mean (SD)

Motor

Process

Motor

Process

Discharge

3 wk

3 mo

1 y

1.45

1.71

2.02

2.18

1.00

1.26

1.23

1.55

1.42

1.52

1.88

2.28

1.18

1.37

1.54

1.59

Authors’ conclusions

Both rehabilitation programmes could be recommended, but additional studies are required to define patients who may benefit specifically from home rehabilitation. Costs should be taken into consideration

Figuras y tablas -
Table 6. Results from the three studies addressing community team‐based rehabilitation
Table 7. Results from the two studies addressing in‐patient rehabilitation

Semlyen 1998

Participant and

group comparisons

Consecutive patients in‐hospital with severe TBI and referred for in‐patient rehabilitation within 4 weeks of injury; age 16 to 62 y

Intervention: multi‐disciplinary specialist rehabilitation service ‐ Hunter’s Moor (HM) (n = 33)

Control: ‘Other rehabilitation’ (OR) in local non‐specialist services in district hospitals (n = 18)

Primary outcomes

Activity and independence: Barthel Index, FIM and Newcastle Independence Assessment Form (NIAF)

Care‐givers' Health: GHQ‐28

Assessment points

1, 2, 3, 6, 12 and 24 mo after injury

Summary of results

Only Z values (BI) and t‐values (FIM and NIAF) are given

HM intervention group was significantly more disabled at outset (as indicated by FIM up to 3 mo, BI up to 6 mo and NIAF up to 12 mo). By 12 mo, therefore, the HM group had caught up with the OR group in level of activity

OR group made significant gains only up to 12 wk on NIAF and FIM cognitive scales, but none on the FIM motor or BI (already at ceiling). By contrast, HM continued to make significant gains up to 24 mo, as assessed by NIAF and BI

Significant improvements in carer distress for the HM group were sustained at 2 y, whereas the OR group showed evidence of deterioration between 6 and 12 mo

No differences in length of stay between groups

Authors’ conclusions

Results support the efficiency of specialist rehabilitation services in achieving lasting gains for patients with more severe disability over similar lengths of stay

Ozedemir 2001

Participant and

group comparisons

Stroke patients referred for rehabilitation after medical stabilisation (n = 60); mean age 59.1 y (SD 5.9)

Group 1: in‐patient rehabilitation (n = 30) ‐ ≥ 2 h/d of formal therapy, 5 d/wk

Group 2: home‐based rehabilitation (n = 30) ‐ team visited home for 2 h/wk and instructed family in home exercises ‐ family provided therapy ≥ 2 h/d, 7 d/wk

Mean duration of rehabilitation 64 d in both groups

Primary outcomes

Impairment: Brunnstrom score, Ashworth (spasticity)

Activity: FIM, Mini‐Mental State Examination (MMSE)

Assessment points

Before and after rehabilitation

Summary of results

Significant group differences in favour of in‐patient group for change in Brunnstrom, FIM and MMSE scores, but no differences in spasticity

Change scores

Group 1

Mean (SD)

Group 2

Mean (SD)

P value

(t‐tests)

Ashworth UE

0.5 (1.2)

0.2 (0.5)

N/S

Ashworth LE

0.2 (1.2)

0.1 (0.3)

N/S

Brunnstrom (UE)

2.0 (1.2)

0.3 (0.6)

< 0.001

Brunnstrom (LE)

2.4 (1.2)

0.8 (0.6)

< 0.001

FIM

59.6 (14.2)

12.3 (13.4)

< 0.001

MMSE

4.8 (5.0)

2.0 (2.1)

< 0.001

Authors' conclusions

Intensive in‐patient rehabilitation provided significantly more favourable functional and cognitive outcomes than home‐based rehabilitation programme

Figuras y tablas -
Table 7. Results from the two studies addressing in‐patient rehabilitation
Table 8. Results from the four studies addressing enhanced intensity of rehabilitation

Kwakkel 1999

Participant and
group comparisons

Stroke patients within 2 wk of onset (n = 101)

All groups received 15 min arm training plus 15 min leg training daily, plus 1.5 h ADL training per wk

In addition, for 30 min 5 d/wk, groups received:

Group 1: intensive arm training (n = 33)

Group 2: intensive leg training (n = 31)

Group 3 (control): inflatable splint (n = 37)

Primary outcomes

ADL ability: Barthel Index (BI)

Walking ability: functional ambulation categories (FAC)

Dexterity: Action Research Arm Test (AR Arm Test)

Assessment points

0, 6, 12, 20, 26, 38, 52 wk

Median (IQR) at 20 wk

Arm training

Leg training

Control

P value

(K‐W test)

BI

17 (14‐20)

19 (16‐20)

16 (10‐19)

 < 0.05

FAC

4 (3‐5)

4 (3‐5)

3 (1‐4)

 < 0.05

AR Arm Test

9 (0‐39)

2 (0‐56)

0 (0‐2)

 < 0.01

Authors’ conclusions

Greater intensity of leg training improves early functional recovery; whereas greater intensity of arm training improves only dexterity, providing further evidence that therapy primarily induces effects on abilities at which training is specifically aimed. Functional gains maintained up to 1 y

Zhu 2001

 

 

 

 

 

 

 

Participant and
group comparisons

Patients aged 12 to 65 y with moderate to severe TBI up to 6 mo post injury (n = 68)

Interventions: multi‐disciplinary rehabilitation at 2 intensities:

  • Intensive: 4 h/d, 5 d/wk (n = 36)

  • Conventional: 2 h/d, 5 d/wk (n = 32)

Primary outcomes

Global outcome: Glasgow Outcome Scale (GOS)

Activity (disability): FIM, Neurobehavioural Cognitive Status Examination (NCSE)

Assessment points

0, 1, 2, 3, 4, 5, 8, 10 and 12 mo

Summary of results

No statistically significant differences in FIM or NSCE between groups. However, significantly greater number of participants achieved maximal FIM and GOS scores within 3 mo, although no differences were noted at later time points and up to 1 year

Outcome
at  6 mo

Intensive (n = 36)

Conventional (n = 32)

P value

(Chi2)

% good GOS

3 mo
12 mo

38

 

14

 

Chi2 3.9, df 1, P value = 0.044

P value = 0.483

% full FIM

3 mo
12 mo

47

 

19

 

Chi2 5.8, df 1, P value = 0.015

P value = 0.242

Authors’ conclusions

Early intensive rehabilitation can improve functional outcomes of patients with TBI in the early months post injury, and hence may increase the chance of their early return to work Intensive rehabilitation in this study speeded up recovery rather than changing final outcomes

Shiel 2001

 

 

 

 

 

 

 

Participant and
group comparisons

Patients with moderate to severe TBI (age 16 to 70 y) admitted for rehabilitation (n = 51); stratified and randomly assigned on age and GCS

Intervention groups

  • Enhanced intensity: intervention by an experienced rehabilitation professional (nurse at one centre, occupational therapist at the other) (N = 24)

  • Routine: multi‐disciplinary rehab (n = 27)

(NB: study conducted across 2 centres, which had very different structures and processes, 1 offering significantly more routine therapy than the other. Participants at each centre were randomly assigned to received standard and enhanced therapy according to their practice

Primary outcomes

Activity (disability): FIM+FAM

Assessment points

Admission and discharge

Summary of results

Despite procedural differences between centres, no significant differences in FIM+FAM change scores were reported between centres. Significant differences were observed between intensive and routine intervention groups and were greatest in the domains of self care, continence, locomotion and psychosocial function. No significant difference in length of stay overall, but possibly skewed by very prolonged LOS for intervention group at 1 centre

Change scores during admission

Enhanced intensity

Median (IQR)

 

Routine

Median (IQR)

P

(Mann‐Whitney)

FIM+FAM Motor

74 (47‐95)

 

21 (2‐48)

< 0.01

FIM+FAM Cognitive

40 (14‐45)

 

12 (5‐22)

< 0.01

Authors’ conclusions

Increased intensity of rehabilitation is associated with enhanced function recovery

Slade 2001

 

 

 

 

Participant and
group comparisons

Patients with acquired brain injury (stroke, TBI or MS) aged 16 to 65 y admitted for rehabilitation (n = 131)

Interventions: multi‐disciplinary rehabilitation at 2 intensities:

  • Intensive: allocated 62.5% of total available therapy time (n = 75)

  • Control: allocated 37.5% of total available therapy time (n = 66)

(NB: Although in theory the intensive group should have received 67% more therapy than controls, in reality, they received only 30% more)

Primary outcomes

Length of stay (LOS)

ADL ability: Modified Barthel Index

Assessment points

Admission and discharge

Summary of results

No significant differences in discharge Barthel scores were reported (data not given), but this is expected, as patients are discharged at the point at which they are sufficiently independent to manage in the community. This question is then whether more intensive therapy reaches that point earlier

Mean LOS for all participants was 84.6 d. Straightforward comparison showed no significant group interactions

However, a multiple regression model was applied to take account of confounders of experimental design that could not be controlled for (impairment mix, community delays, missed treatment, etc.); this demonstrated a 14‐d reduction for the intensive group

Authors’ conclusions

Intensive rehabilitation has the potential to reduce length of stay, but concurrently, LOS in both groups was increased by 16 d as the result of external delays in discharge

Figuras y tablas -
Table 8. Results from the four studies addressing enhanced intensity of rehabilitation
Table 9. Results from the two studies addressing early vs delayed rehabilitation

Andelic 2012

Participant and group comparisons

Patients with severe TBI; mean age 29.4 y

Intervention:continuous chain of rehabilitation from specialist on ITU directly into specialist subacute rehabilitation post discharge from ITU (n = 33).
Control: delayed subacute rehabilitation after a period of time waiting in a local hospital or nursing home. Some participants received no rehabilitation (n = 31)

Primary outcomes

Disability: Glasgow Outcome Scale Extended (GOSE)

Secondary outcomes

Disability: Disability Rating Score (DRS)

Employment status: return to work

Living situation: at home with or without care, or in a nursing home

Assessment points

12 months post injury (n = 61)

Summary of results

Disability (GOSE) at 12 mo significantly less in the early rehabilitation group than in the control group

Significantly higher percentage of participants in the early rehabilitation group were living at home when compared with controls

Non‐significant trend towards higher rate of return to work in the early rehabilitation group than in the control group

Non‐significant trend towards shorter overall length of stay (acute hospital and rehabilitation unit) in the early rehabilitation group

Outcomes

Intervention

Control

P value

Favourable GOSE (6‐8)

71%

37%

0.007

% living at home

81

53

0.06

Authors' conclusions

Early comprehensive rehabilitation in a continuous chain leads to better functional outcomes at 12 months post injury among patients with severe TBI

Bai 2012

Participant and group comparisons

Patients with moderate to severe intracerebral haemorrhage; mean age 61 y

Intervention: early rehabilitation commencing in the Emergency Department and continuing for 6 mo (n = 181)

Controls: standard medical care (n = 183)

Primary outcomes

Impairment: Fugl‐Meyer Assessment (FMA)

Disability: Modified Barthel Index (MBI)

Assessment points

Outcome measures administered at 1, 3 and 6 mo

Summary of results

At baseline, post hoc testing showed no significant differences between FMA and MBI scores in the 2 groups

At 1, 3 and 6 mo, intervention group had significantly higher FMA and MBI scores

Authors' conclusions

Early rehabilitation can significantly improve ADLs and motor recovery in patients with intracranial haemorrhage

Figuras y tablas -
Table 9. Results from the two studies addressing early vs delayed rehabilitation
Table 10. Results from the two studies addressing the therapeutic environment as a model of rehabilitation

Cicerone 2008

Participant

and group

comparisons

Mixed severity traumatic brain injury; mean age 36.6 y

Intervention: intensive cognitive rehabilitation provided in a therapeutic environment (n = 34) with a focus on group work

Control: standard neurorehabilitation; mostly individual, discipline‐specific therapy (n = 34)

Primary

outcomes

Community integration: Community Integration Questionnaire (CIQ)

Life satisfaction: Perceived Quality of Life Scale (PQOL)

Secondary

outcomes

Neuropsychological functioning

Perceived self‐efficacy

Vocational outcome: Vocational Integration Scale (VIS)

Assessment

points

2 wk before treatment, 2 wk post treatment and 6 mo follow‐up

Summary of

results

Treatment arm showed significantly improved community integration and quality of life scores ‐ not seen in control arm

Self efficacy was significantly improved in the treatment arm – another improvement not seen in the control arm

Additionally, treatment group had a significantly higher rate of employment compared with control group

Standard neurorehabilitation

Outcome

measures

Pre‐Tx

Post‐Tx

Follow‐up

P value

CIQ

12.1

11.7

12.9

> 0.05

PQOL

61.2

62.2

59.6

> 0.05

Authors'

conclusions

This trial demonstrates that an intensive cognitive rehabilitation programme can produce significantly better outcomes when compared with standard neurorehabilitation

Salazar

2000

Participant and

group comparisons

Active duty military personnel with moderate to severe TBI; mean age 25 y

Intervention: 8‐week intensive in‐patient cognitive‐behavioural programme (n = 67)

Control: limited home programme of weekly telephone support from psychiatric nurse (educational material, counselling and suggested home exercises) (n = 53)

Primary

outcomes

Work status: return to work

return to fitness for military duty

Assessment

points

1 y

Summary

of results

No overall differences in outcomes between groups

Post hoc analysis demonstrated significant group interaction (in favour of the intervention group) for ‘fitness for military duty’ at 1 y for members of the more severe subgroup, who were unconscious for >1 h

Vocational

status

at 1 y

Intervention

% achieved

Control

% achieved

Difference

P value

(Fisher's exact)

Return to work

90%

94%

4% (‐5,14)

N/S

Fit for military duty

73%

66%

7% (‐10.24)

N/S

Post hoc analysis of subgroup unconscious for > 1 h (n = 75)

(n = 35)

(n = 40)

Difference

P value

Fit for military duty

80%

58%

22%

0.05

Authors' conclusions

Overall benefit of in‐patient cognitive rehabilitation programme similar to that of limited home rehabilitation, although institutional therapy may be beneficial for selected patients with more severe TBI

Figuras y tablas -
Table 10. Results from the two studies addressing the therapeutic environment as a model of rehabilitation