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

Page 2002b.

Methods Randomisation details were not provided
 Blinded outcome assessor
 No information about withdrawals
 Multicentre, outpatients
Participants USA
Recruited through letters sent to people who experienced a cerebrovascular accident and were discharged from outpatients therapy provided at 4 rehabilitation hospitals
14 participants: 4 intervention, 5 control, 5 no treatment
Inclusion criteria: stroke between 4 weeks and 6 months; 10° of active extension to the metacarpophalangeal and interphalangeal joints and 20° at wrist
Exclusion criteria: severe cognitive impairment, excessive spasticity and pain
Mean age (SD): intervention group: 73.5 (6.35) years, control group: 67.4 (13.8) years, no intervention group 68.2 (14.13) years
 % women: intervention group 0%, control group 20%, no treatment group 80%
Stroke details: only Ischaemic; 50% with right hemiparesis in treatment group, 20% with right hemiparesis in control group, 60% with right hemiparesis in no treatment group
Time since stroke, mean (SD): intervention group 5 (0.8) months, control group 4.9 (0.9) months, no treatment group 4.3 (0.67) months
Interventions This trial had 3 arms: the intervention group performed mCIMT; a control group performed usual care; and the third group performed no treatment
mCIMT versus control versus no treatment
mCIMT: physical therapy and occupational therapy focused on functional tasks by the more affected limb, stretching, stand/balance, gait training, shaping techniques on 2 or 3 functional tasks
 Amount of restraint: 5 waking hours per day
Anatomical region restraint: arm and hand
Control: physical and occupational therapy focused on functional tasks by the more affected limb and PNF
Session duration: 1 hour per day, 3 days per week, 10 weeks for each group
Outcomes Measures pre/post treatment
  • Motor function: ARAT

  • Perceived arm motor function: MAL

  • Arm motor impairment: FMA

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "... all subjects randomly assigned ... with equal probability"
 Comment: insufficient information to permit judgment
Allocation concealment (selection bias) Unclear risk No information provided
Blinding (performance bias and detection bias) 
 All outcomes Low risk Quote: "...a blinded rater again administered the instruments to all subjects"
Incomplete outcome data addressed? (Post‐treatment) Unclear risk The study provided no information about withdrawals