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. 2015 Nov 7;2015(11):CD006876. doi: 10.1002/14651858.CD006876.pub4

Kutner 2010

Methods RCT
Methods of randomisation: sealed envelope method
Participants Country: USA
Sample size: 21 participants (11 in experimental group and 10 in combined therapy group)
Inclusion criteria: first clinical stroke diagnosis; time since stroke between 3 and 9 months; Mini‐Mental State Examination score of > 24; being able to stand for 2 minutes; passive range of motion ≥ 45° for shoulder abduction, flexion, or external rotation and pronation of the forearm; active wrist extension ≥ 10°; active thumb extension and ≥ 10° of extension in at least 2 additional digits
Exlusion criteria: not described
Interventions 2 groups:
  1. 60 hours of repetitive task training over the course of 3 weeks

  2. 30 hours of repetitive task training plus 30 hours of robotic‐assisted training with the Hand Mentor device over the course of 3 weeks

Outcomes Outcomes were recorded at baseline, at the end of intervention, and at 2 months postintervention
Primary outcome measure: health‐related quality of life (SIS)
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "participants were randomly assigned by the sealed envelope method"
Allocation concealment (selection bias) Unclear risk It was not described whether the sealed envelopes were opaque
Blinding of outcome assessment (detection bias) All outcomes Low risk Quote: "Research staff blinded to treatment assignment conducted interview‐based outcome assessments."
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement