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. 2015 Oct 8;2015(10):CD004433. doi: 10.1002/14651858.CD004433.pub3

Brunner 2012.

Methods Randomisation by computer
Blinded outcome assessor
Post‐treatment withdrawals 6%
Multicentre, inpatients and outpatients
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
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
Outcomes Measures pre/post treatment
  • Arm motor function: ARAT

  • Dexterity: 9HPT

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"