Wolf 2006.
| Methods | Randomisation automated, balanced with respect to sex, premorbid handedness, side of stroke and level of function Blinded outcome assessor Post‐treatment withdrawals: 8%; follow‐up withdrawals: 17% Multicentre, outpatients | |
| Participants | USA Recruited from 247 facilities spanning the 7 participating sites 222 participants: 106 intervention, 116 control Inclusion criteria: cerebrovascular accident between 3 and 9 months; 10° of active extension to the metacarpophalangeal and interphalangeal joints and 20° at wrist or 10° of active extension to the metacarpophalangeal and interphalangeal joints of two digits, and at wrist, 10° of thumb abduction/extension Exclusion criteria: scored less than 24 on the MMSE; physician‐determined medical problems could interfere with participation; excessive pain of the paretic extremity; substantial use of the paretic arm in daily life as determined by a score ≥ 2.5 on the Motor Activity Log Mean (SD) age: intervention group: 61 (13.5), control group: 63.43 (12.6) years % women: intervention group 34.9, control group: 37.1 Stroke details: ischaemic or haemorrhagic; 47.2% with hemiparesis of the dominant side in treatment group, 51.75% with hemiparesis of the dominant side in control group Time since stroke, mean (SD): intervention group 5.9 (2.1), control group 6.2 (2.3) months |
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| Interventions | CIMT versus control CIMT: adaptive task practice (shaping) and standard task training of the paretic limb Amount of restraint: 90% of waking hours Anatomical region restraint: hand Control: usual and customary care ranged from no treatment to the application of mechanical interventions or various occupational and physical therapy approaches in the home Session duration: CIMT: 6 hours per day, 7 days per week, 2 weeks; control: not provided. |
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| Outcomes | Measures pre/post treatment and follow up at 4, 8, and 12 months
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Participants were randomly assigned to the experimental (CIMT) or control condition using an automated, centralized system administered by the data management centre" |
| Allocation concealment (selection bias) | Low risk | Centralised |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Blinding of outcome assessor |
| Incomplete outcome data addressed? (Post‐treatment) | Low risk | 8/106 missing from intervention group (5 withdrew, 1 moved, 1 stroke, 1 poor health), 15/116 missing from control group (7 withdrew, 2 moved, 2 died) |