Bergheim 2010.
| Methods | Randomisation by computer Blinded outcome assessor No withdrawals Single centre, inpatients |
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| Participants | Norway Recruited from stroke unit and the neurological department of geriatric medicine of Ullevaal University Hospital 4 participants: 2 intervention, 2 control Inclusion criteria: cerebrovascular accident between 14 and 21 days; 10° of active extension in the finger and 20° in the wrist; ability to walk indoors without the use of walking aids; sufficient cognitive function Exclusion criteria: cerebral haemorrhage, prior stroke, unstable medical status, second cerebral diseases that were difficult to differentiate from a stroke, and previous illness/injury that significantly impaired function in arms Mean age (SD): intervention group: 70.5 (13.4) years, control group: 76.5 (4.9) years % women: intervention group 50%, control group: 50% Stroke details: only ischaemic, 0% with right hemiparesis with 0% paresis of the dominant side in treatment group, 50% with right hemiparesis with 50% paresis of the dominant side in control group Time since stroke: 14‐21 days after stroke onset |
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| Interventions | mCIMT versus control
mCIMT: functional activities through shaping approach Amount of restraint: 6‐7 hours per day Anatomical region restraint: hand Control: mono and bilateral activities Session duration: 1 hour per day, 5 days/week, 2 weeks for both groups |
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| Outcomes | Measures pre/post treatment and follow‐up at 3 months
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "the randomisation was performed from a computer generated list" |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Enrolled patients consented in writing and orally and were randomized by closed numbered envelopes participation respectively group mCIMT or TF [traditional physiotherapy]" |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "The outcome was examined by a physiotherapist blinded to therapy patients received" |
| Incomplete outcome data addressed? (Post‐treatment) | Unclear risk | No missing outcome data |