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

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
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
Outcomes Measures pre/post treatment, follow up at 3 to 4 months
  • Perceived arm motor function: MAL

  • Dexterity: GPT

  • Arm motor impairment: FMA2

  • Neurophysiological test: TMS

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