Methods |
RCT Method of randomisation: stratified randomisation with random permuted blocks and random block size Blinding of outcome assessors: yes Adverse events: not reported Deaths: not reported Drop outs: 15 (7 in EXP group, 8 in CTL group) ITT: yes |
Participants |
Country: Canada 63 participants (32 in EXP group, 31 in CTL group) Ambulatory at study onset Mean age: 61 to 63 years (CTL and EXP group respectively) Inclusion criteria: age between 30 and 89 years, with first or second episode of ischaemic stroke with residual deficit, Barthel Ambulation Subscore > 10, gait speed between 0.1 and 0.6 m/s Exclusion criteria: haemorrhagic stroke, ability to understand and follow verbal instructions, major medical problems (diabetes, cancer, aphasia, orthopaedic disorders) interfering with the intervention |
Interventions |
2 arms:
CTL group received physiotherapy in an eclectic approach, 5 times per week for 8 weeks (5 hours per week)
EXP group received treadmill training without body weight support, reciprocal stepping and limb loading for the same time and frequency
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Outcomes |
Outcomes were recorded at baseline, at the end of the intervention phase and 3 months later Primary outcomes: gait speed by walking 5 metres, 10 metres or 30 metres at preferred speed Secondary outcomes: lower extremity function (FMA), Timed Up and Go, Functional Independence (Barthel Ambulation Subscore) |
Notes |
Contamination addressed in the study design by issues of location and personnel |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Stratified randomisation with random permuted blocks and random block size |
Allocation concealment (selection bias) |
Low risk |
After randomisation, treating therapists were informed about assignment |
Blinding of outcome assessment (detection bias) All outcomes |
Low risk |
Outcome assessor was blinded to group assignment |