توانبخشی چند‐رشتهای برای آسیب اکتسابی مغزی در بزرگسالان در سنین کار
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Characteristics of studies
Characteristics of included studies [ordered by study ID]
| 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) | High risk | Assessors not blinded |
| Incomplete outcome data (attrition bias) | 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. |
| 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) | 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) | 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. |
| 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) | 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) | 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. |
| Methods | Unblinded controlled trial | |
| Participants | Moderate to severe TBI Carers n = 96 recruited: treatment group n = 69, control group n = 27 | |
| Interventions | Head Injury Neurorehabilitation Team (HINT) | |
| Outcomes | Carers' perception of how well informed they are | |
| 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) | High risk | Assessors not blinded |
| Incomplete outcome data (attrition bias) | 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. |
| 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) | 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) | 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. |
| 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) | 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) | 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). |
| Methods | Single‐blind RCT | |
| Participants | Middle cerebral artery stroke | |
| Interventions | Intensive arm or leg training by physio/occupational therapists vs immobilisation with inflatable splint | |
| Outcomes | Primary outcomes: Barthel ADL 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) | 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) | 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 |
| Methods | Controlled study | |
| Participants | Stroke patients n = 60 | |
| Interventions | In‐patient rehabilitation vs home exercise programme | |
| Outcomes | Impairment: Ashworth Scale; Brunnstrom stages; Mini‐Mental State Examination (MMSE) | |
| 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) | 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) | 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 |
| Methods | Single‐blind RCT | |
| Participants | Moderate to severe TBI | |
| Interventions | Treatment as needed with full MD programme vs single session ‐ educational input | |
| Outcomes | Impairment: Problem checklist Health status: Short‐Form Health Survey (SF‐36) | |
| 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) | 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) | 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 |
| Methods | Single‐blind RCT | |
| Participants | Moderate to severe TBI | |
| Interventions | Community‐based outreach MD team | |
| Outcomes | Activity: Barthel Index; Functional Assessment Measure (FIM+FAM) | |
| 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) | 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) | 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 |
| Methods | Unblinded RCT | |
| Participants | Defence veterans moderate to severe TBI | |
| Interventions | In‐patient: intensive 8‐wk programme vs | |
| Outcomes | Work status: return to work | |
| 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) | High risk | Not blinded |
| Incomplete outcome data (attrition bias) | 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 |
| Methods | Unblinded controlled study | |
| Participants | Patients with moderate to severe n = 51 | |
| 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 | |
| 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) | High risk | Unblinded |
| Incomplete outcome data (attrition bias) | 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 |
| Methods | Unblinded RCT | |
| Participants | Patients with moderate to severe TBI n = 51 | |
| Interventions | Intensive rehabilitation (with additional healthcare professional experienced in BI) vs standard treatment | |
| Outcomes | Disability: Functional Assessment Measure (FIM+FAM) | |
| 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) | 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) | 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 |
| 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) | 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) | 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 |
| Methods | Unblinded RCT | |
| Participants | Stroke patients discharged from hospital | |
| Interventions | Out‐patient physiotherapy/occupational therapy for up to 6 mo | |
| 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) | Low risk | Blinded |
| Incomplete outcome data (attrition bias) | Low risk | Attrition rate acceptable |
| Selective reporting (reporting bias) | Low risk | Results for all primary and secondary outcome measures reported |
| 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) | |
| Outcomes | Symptoms: Post concussion: Rivermead Post‐concussion symptoms Questionnaire (RPQ) | |
| 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) | 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) | 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 |
| Methods | Single‐blind RCT | |
| Participants | TBI ‐ all severities (but only if admitted to hospital) | |
| Interventions | Oxford Head Injury Service (OxHIS) | |
| Outcomes | Symptoms: Post concussion: Rivermead Post‐concussion symptoms Questionnaire (RPQ) | |
| 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) | Low risk | Outcome assessors adequately blinded |
| Incomplete outcome data (attrition bias) | Low risk | Attrition acceptable given design ‐ study author communication |
| Selective reporting (reporting bias) | Low risk | Results for all primary and secondary outcome measures reported |
| Methods | Single‐blind RCT | |
| Participants | Stroke patients ‐ ≥ 1 y since stroke (mean 2.9 y) | |
| Interventions | Late treatment: | |
| Outcomes | Activity: Functional Independence Measure ‐ Motor subscale (FIM‐Motor) | |
| 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) | Low risk | Outcome assessors adequately blinded |
| Incomplete outcome data (attrition bias) | High risk | Attrition rate unacceptably high |
| Selective reporting (reporting bias) | Low risk | Results for all primary and secondary outcome measures reported |
| 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) | 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) | 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 |
| Fatally flawed: small numbers with high chance of type II error and poorly matched groups at baseline | |
| 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 | |
| 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 | |
| Fatally flawed: > 40% attrition at 1‐y follow‐up. Outcome measured by questionnaire only, with no validating evidence presented | |
| Low methodological quality as per van Tulder criteria | |
| 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]
| 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 |
| Outcomes | Primary outcome: Return to work. |
| Starting date | March 2009 |
| Contact information | Haukeland University Hospital, Bergen, Norway |
| Notes |
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.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
| 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. |
| 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 |
| 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. |
| 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. |
| 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. | |||||
| 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:
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. | |||||
| 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)
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
| |||
| 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 | ||||
| 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 | |||
| Kwakkel 1999 | Participant and | 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 | 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:
| |||
| 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 | Intensive (n = 36) | Conventional (n = 32) | P value (Chi2) | ||
| % good GOS 3 mo | 38
| 14
| Chi2 3.9, df 1, P value = 0.044 P value = 0.483 | ||
| % full FIM 3 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 | 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
(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 | 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:
(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 | ||||
| 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). | ||
| 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 | |||
| 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 | ||||
