Methods | Parallel‐group design Participants randomised to groups using a stratified block randomisation scheme Concealed allocation to groups not reported 15% drop outs at the end of the treatment phase, number of drop outs not reported at 3 and 6‐month follow‐ups Blinding of outcome assessors to group allocation | |
Participants | 10 participants in the EXP group, 8 participants in the CTL 1 group and 9 participants in the CTL 2 group Non‐ambulatory at study onset Inclusion criteria: resident within 50 km of Quebec; aged 40 to 80 years; less than 7 days after onset of first stroke; clinically identifiable middle cerebral artery syndrome of thromboembolic origin involving sub‐cortical structures confirmed by CT; under medical supervision of study neurologists; informed consent; middle‐band disability according to Garraway (i.e. excluded patients independent in ambulation as well as those who were unconscious) Exclusion criteria: other neurological problems; major medical problems that would incapacitate functional capacity (patients independent in ambulation were excluded) |
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Interventions | Treated as inpatients for 6 weeks for a mean of 1.74 (SD 0.15) (EXP), 1.79 (SD 0.10) (CTL 1) and 0.72 (SD 0.10) (CTL 2) hours per day Early intensive task‐oriented physiotherapy (EXP): treatment started as early as possible after stroke and included treadmill training (no body weight support was provided using a harness), tilt table exercises and resisted exercises using isokinetic equipment Early intensive traditional physiotherapy (CTL 1): treatment started as early as possible after stroke and included traditional physiotherapy based on neurophysiological techniques Delayed non‐intensive traditional physiotherapy (CTL 2): treatment started later after stroke and included less intense traditional physiotherapy based on neurophysiological techniques | |
Outcomes | Assessed at baseline, after treatment phase and 3 and 6 months later:
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Notes | 3 and 6‐month follow‐up data not reported We chose to compare the EXP and CTL 1 groups only for this review because they had the same intensity and starting time of therapy | |
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 | Unclear risk | Evaluators were blind to group allocation |