| Methods |
RCT
Method of randomisation: block sampling method (each block contained 6 participants: 4 experimental group and 2 control group)
Blinding of outcome assessors: no
Adverse events: 5 (3 in experimental group, 2 in control group)
Deaths: none
Dropouts: 11 (8 in experimental group, 3 in control group)
ITT: no (stated, but 2 participants from the control group were excluded from analysis) |
| Participants |
Country: Israel
67 participants (at October 2006) (37 in treatment group, 30 in control group)
Non‐ambulatory at study onset
Mean age: 60 years
Inclusion criteria: first stroke, until 3 months after stroke
Exclusion criteria: not provided |
| Interventions |
2 arms:
|
| Outcomes |
Outcomes were recorded at baseline and after 3, 6, and 9 weeks:
|
| Notes |
Published and unpublished data provided by the authors. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Block sampling |
| Allocation concealment (selection bias) |
Unclear risk |
Unclear |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Not done |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk was enough to induce clinically relevant bias into intervention effect estimate. |