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
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.

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

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

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

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
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

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

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