Methods | Parallel‐group design Participants randomised to groups (block randomisation with participants stratified for walking speed) Concealed allocation to groups using sealed, opaque envelopes 13% drop outs at the end of the treatment phase Blinding of outcome assessors to group allocation | |
Participants | 22 participants in the EXP 1 group, 22 participants in the EXP 2 group and 25 participants in the CTL group Inclusion criteria: hemiparesis caused by ischaemic stroke; impaired gait (takes 5 to 60 seconds to walk 10 metres); hemiparesis more than 4 weeks; no or slight spasticity (0 or 1 on the Ashworth scale); able to walk without assistance (FAC of 3 or more); informed consent Exclusion criteria: previous treadmill training; class C or D exercise risk (American College of Sports Medicine Guidelines); cognitive deficits (less than 26 out of 30 on Mini Mental State Examination); movement disorders, orthopaedic or other gait influencing disease | |
Interventions | Treated as inpatients for 3 x 30‐minutes sessions (EXP 1 and EXP 2) or 45‐minute sessions (CTL) per week for 4 weeks Speed‐dependent treadmill training with body weight support (EXP 1): participants walked on a treadmill without therapist assistance, speed was progressed using an aggressive protocol Limited progressive treadmill training with body weight support (EXP 2): participants walked on a treadmill with therapists assisting the walking cycle, speed was progressed using conservative protocol Conventional gait therapy (CTL): traditional physiotherapy based on neurophysiological techniques | |
Outcomes | Assessed at baseline and after treatment phase:
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Notes | The rating of concealed allocation and the allocation concealment classification were changed based on correspondence from the trialist In the update of 2005 the data from this study were divided into 2 comparisons: half of the control group data were used for each comparison. Based on the raw data we combined both experimental groups into 1 group. According to Chapter 16.5.4 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) we combined both treadmill groups, group LTT and group STT together to one treadmill group (to create a single pair‐wise comparison) and compared it with the control group We used raw data provided by the trialists |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded |