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

Alberts 2004.

Methods Randomisation automated and balanced with respect to sex, premorbid handedness, side of stroke and level of function
 Blinded outcome assessor
 No information about withdrawals
 Multicentre, outpatients
Participants USA
Recruited from 247 facilities spanning the 7 participating sites participating in a multi‐site trial
10 participants: 5 intervention, 5 control
Inclusion criteria: cerebrovascular accident between 3 and 9 months, 10° of active extension to the metacarpophalangeal and interphalangeal joints and 20° at wrist, minimum passive range of motion of 90° for shoulder flexion and abduction
Exclusion criteria: score of < 24 on the MMSE, physician‐determined major medical problems that would interfere with participation
Mean age (SD): intervention group: 65 (8.2) years, control group: 63.4 (15.5) years
 % women: intervention group 60%, control group: 40%
Stroke details: only ischaemic, 20% with right hemiparesis in each group
Time since stroke, mean (SD): intervention group 6.4 (1.1) months, control group 5.6 (1.5) months
Interventions CIMT versus no treatment
 CIMT: shaping or adaptive task practice and repetitive task practice techniques
 Amount of restraint: 90% of waking hours per day
 Anatomical region restraint: hand
Session duration: 6 hours per day, 5 days per week for 2 weeks
Outcomes Measures pre/post treatment
  • Arm motor function: WMFT

  • Arm motor impairment: FMA, grip/force

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Sequence generation by random automated generator
 Quote: "Ten patients were randomly assigned to 1 of 2 groups"
Allocation concealment (selection bias) Low risk Central allocation
Blinding (performance bias and detection bias) 
 All outcomes Low risk Quote: "An evaluator blinded to group assignment performed pre‐ and post‐ WMFT and FMA assessments"
Incomplete outcome data addressed? (Post‐treatment) Unclear risk The study provided no information about withdrawals