Methods |
Parallel‐group design Participants randomised to groups using a stratified block randomisation scheme Allocation was concealed using sealed and numbered envelopes 21% drop outs at the end of the treatment phase, 48% drop outs at the 3‐month follow‐up Blinding of outcome assessors to group allocation |
Participants |
50 participants in the EXP group and 50 participants in the CTL group Inclusion criteria: admitted to the Jewish Rehabilitation Hospital for physical rehabilitation after stroke; abnormal gait; no severe cardiac problems; no comorbid conditions contraindicating treadmill training; not cerebellar, bilateral or brain stem stroke; able to understand simple commands; anticipated length of stay of at least 4 weeks; onset of stroke no more than 6 months prior to recruitment; able to ambulate pre‐stroke; first admission during study period; treadmill training time slot available; informed consent |
Interventions |
Treated as inpatients for 4 x 20‐minute session per week for 6 weeks Treadmill training with body weight support (EXP): participants walked on a treadmill with partial body weight support using a harness and the assistance of 1 to 2 therapists Treadmill training only (CTL): participants walked on a treadmill with the assistance of 1 to 2 therapists; no body weight support was provided using a harness |
Outcomes |
Assessed at baseline, after treatment phase and 3 months later:
preferred walking speed over 3 m (personal assistance and gait aids could be used)
walking endurance ‐ maximum distance walked up to a maximum of 320 m (personal assistance and gait aids could be used)
Berg Balance Scale
Stroke Rehabilitation Assessment of Movement
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Notes |
The rating of concealed allocation and the allocation concealment classification were changed based on correspondence from the trialist Data divided into 2 comparisons, see Visintin 1998a and Visintin 1998b
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Drawing lots out of a box |
Allocation concealment (selection bias) |
Low risk |
Allocation was concealed using sealed and numbered envelopes |
Blinding of outcome assessment (detection bias) All outcomes |
Low risk |
Outcome assessors were blind to group allocation |