Page 2002b.
Methods | Randomisation details were not provided Blinded outcome assessor No information about withdrawals Multicentre, outpatients | |
Participants | USA Recruited through letters sent to people who experienced a cerebrovascular accident and were discharged from outpatients therapy provided at 4 rehabilitation hospitals 14 participants: 4 intervention, 5 control, 5 no treatment Inclusion criteria: stroke between 4 weeks and 6 months; 10° of active extension to the metacarpophalangeal and interphalangeal joints and 20° at wrist Exclusion criteria: severe cognitive impairment, excessive spasticity and pain Mean age (SD): intervention group: 73.5 (6.35) years, control group: 67.4 (13.8) years, no intervention group 68.2 (14.13) years % women: intervention group 0%, control group 20%, no treatment group 80% Stroke details: only Ischaemic; 50% with right hemiparesis in treatment group, 20% with right hemiparesis in control group, 60% with right hemiparesis in no treatment group Time since stroke, mean (SD): intervention group 5 (0.8) months, control group 4.9 (0.9) months, no treatment group 4.3 (0.67) months |
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Interventions | This trial had 3 arms: the intervention group performed mCIMT; a control group performed usual care; and the third group performed no treatment mCIMT versus control versus no treatment mCIMT: physical therapy and occupational therapy focused on functional tasks by the more affected limb, stretching, stand/balance, gait training, shaping techniques on 2 or 3 functional tasks Amount of restraint: 5 waking hours per day Anatomical region restraint: arm and hand Control: physical and occupational therapy focused on functional tasks by the more affected limb and PNF Session duration: 1 hour per day, 3 days per week, 10 weeks for each group |
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Outcomes | Measures pre/post treatment
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "... all subjects randomly assigned ... with equal probability" Comment: insufficient information to permit judgment |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "...a blinded rater again administered the instruments to all subjects" |
Incomplete outcome data addressed? (Post‐treatment) | Unclear risk | The study provided no information about withdrawals |