Brunner 2012.
Methods | Randomisation by computer Blinded outcome assessor Post‐treatment withdrawals 6% Multicentre, inpatients and outpatients |
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Participants | Norway Recruited from 2 hospitals in the City of Bergen 30 participants: 14 intervention, 16 control Inclusion criteria: cerebrovascular accident between 2 and 16 weeks; ability to extend the affected wrist and fingers at least 10° Exclusion criteria: additional neurological diseases, unstable medical conditions, musculoskeletal disorders affecting arm mobility and severe cognitive impairment Mean age (SD): intervention group: 61 (10) years, control group: 64.8 (12.8) years % women: intervention group 21%, control group: 50% Stroke details: ischaemic or haemorrhagic; 43% with right hemiparesis in treatment group, 37% with right hemiparesis in control group Time since stroke, mean (SD): intervention group 1.6 (1.3) months, control group 1.23 (0.8) months |
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Interventions | mCIMT versus control mCIMT: task‐related arm training, strength training, mobility training with shaping approach and self training focusing on unilateral activities Amount of restraint: 4 hours per day Anatomical region restraint: hand Control: task‐related arm training, strength training, mobility training with shaping approach and self training focusing on bilateral activities Session duration: 4 hours a week with physiotherapist plus 2‐3 hours everyday of self‐training for 4 weeks for both groups |
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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) | Low risk | Quote: "A randomized controlled trial was applied. A computerized random numbers generator was used for randomising the patients in blocks of four patients into a modified constraint‐induced movement therapy or a bimanual training group" |
Allocation concealment (selection bias) | Low risk | Quote: "Opaque, sealed envelopes were prepared by a person not involved in the study, classifying the patients into one of the two groups" |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "The randomizations led to a balanced allocation, and blinded raters secured unbiased assessments" |
Incomplete outcome data addressed? (Post‐treatment) | Low risk | Quote: "There was two drop‐outs, one in each group, due to other medical problems" |