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. 2014 Jan 23;2014(1):CD002840. doi: 10.1002/14651858.CD002840.pub3

Duncan 2011

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
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
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
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