Boake 2007.
Methods | Randomisation: stratified by age and NIHSS, other details were not reported Blinded outcome assessor Post‐treatment withdrawals 22%, follow‐up withdrawals: 11% Single centre, inpatients and outpatients | |
Participants | USA Recruited from admissions to the University Hospital of Memorial Hermann 23 participants: 10 intervention, 13 control Inclusion criteria: cerebrovascular accident within 14 days; score 1 to 3 on the motor arm item of the NIHSS; 10° of active movement in the thumb and 2 or more fingers of the affected hand. Exclusion criteria: not reported Mean age (SD): intervention group: 63.1 (14.3)years, control group: 58.9 (14) years % women: intervention group 30%, control group: 38% Stroke details: ischaemic or haemorrhagic, 40% with right hemiparesis in treatment group, 54% with right hemiparesis in control group Time since stroke, mean (range): intervention group 3.3 (3 to 4.1) months, control group 3.3 (3 to 4.3) months |
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Interventions | mCIMT versus control mCIMT: functional tasks with shaping techniques Amount of restraint: 90% of waking hours per day Anatomical region restraint: hand Control: ADL with either hand, improvement of strength, muscle tone and range of motion of the affected arm Session duration: 3 hours per day, 6 days per week, 2 weeks for each group |
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Outcomes | Measures pre/post treatment, follow up at 3 to 4 months
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "patients underwent baseline testing and were randomly allocated to either CIMT or traditional therapy" |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "Outcome evaluations were performed by personnel from outside ... who were blind to treatment assignment" |
Incomplete outcome data addressed? (Post‐treatment) | High risk | 1/10 missing from intervention group (due to incomplete data), 4/13 missing from control group (due incomplete data and injuries). Reasons for missing data outcomes possibly related to the true effect, with imbalance across intervention and control groups |