Methods | Parallel‐group design Participants were randomised to 3 groups using a stratified randomisation procedure Allocation to groups was concealed 11.5% drop outs at the end of the treatment phase Outcome assessors were not rigorously blinded to group allocation | |
Participants | Country: USA 408 participants Inclusion criteria: age of 18 years or older, a stroke within 45 days before study entry and the ability to undergo randomisation within 2 months after the stroke, residual paresis in the leg affected by stroke, the ability to walk 3 metres with assistance from no more than 1 person and the ability to follow a 3‐step command, the treating physician’s approval of participation in the study, a self selected speed for walking 10 metres of less than 0.8 m per second, and residence in the community by the time of randomisation Exclusion criteria: dependency on assistance in activities of daily living before the stroke, contraindications to exercise, pre‐existing neurologic disorders and inability to travel to the treatment site |
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Interventions | 3 groups: Group 1 (EXP) received training on a treadmill with the use of BWS 2 months after the stroke had occurred (early locomotor training) Group 2 (EXP) received this training 6 months after the stroke had occurred (late locomotor training) Group 3 (CTL) participated in an exercise programme at home managed by a physical therapist 2 months after the stroke (home‐exercise programme) Each intervention included 36 sessions of 90 minutes each for 12 to 16 weeks |
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Outcomes | The primary outcome was the proportion of participants in each group who had an improvement in functional walking ability 1 year after the stroke Further outcomes were: walking speed; distance walked in 6 minutes; number of steps walked per day; Stroke Impact Scale; FMA legs; Berg Balance Scale; Specific Balance Confidence score |
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Notes | We combined the results of both EXP groups (Group 1 and Group 2) as 1 group and compared them with the results of the CTL group (Group 3) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Authors describe that participants were randomly assigned to 1 of 3 groups. Authors describe a stratified randomisation procedure in ratios of 140:120:120 stratified by severity. The method of randomisation generation is, however, not described |
Allocation concealment (selection bias) | Low risk | The method of allocation concealment is described as: "The study coordinator registers the patient, enters the baseline data into the web based database system, and then obtains group assignment from the data management and analysis center." |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Per diem therapists did the assessments |