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

Volpe 2008

Methods RCT Method of randomisation: not stated
Participants Country: USA Sample size: 21 participants (11 in treatment group, 10 in control group) Inclusion criteria: people after stroke with impaired arm and hand mobility for at least 6 months Exclusion criteria: not able to follow simple instructions, minimally impaired (Fugl‐Meyer shoulder‐elbow section > 33 points), neurosurgical procedure, second stroke, fixed contracture
Interventions 2 groups:
  1. control group: intensive movement protocol with a trained physiotherapist

  2. treatment group: robotic training with the InMotion2 robot (the commercial version of MIT‐Manus)


All participants had an identical number of treatment sessions, and the sessions were of the same duration (1 hour per session, 3 times a week for 6 weeks)
Outcomes Outcomes were recorded at 3 preliminary evaluations (Pre1, Pre2, Pre3), at midpoint, at discharge, and at 3‐month follow‐up
  • FMA

  • Motor Power Scale for shoulder/elbow (0 to 70)

  • MAS

  • Stroke Impact Scale (SIS 2.0)

  • ARAT

  • shoulder dislocation (joint stability; maximum cm of displacement = 9)

  • pain scale from the FMA (0 to 24)

  • Beck Depression Scale (maximum = 63)

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information about the sequence generation process
Allocation concealment (selection bias) Unclear risk Insufficient information about the concealment of allocation
Blinding of outcome assessment (detection bias) All outcomes High risk No blinding of outcome assessment was done
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement