Reinkensmeyer 2012.
Methods | RCT | |
Participants | Recruited from local hospitals and stroke support groups in Orange County, California 26 participants: 13 intervention, 13 control Inclusion criteria: single stroke and ≥ 3 months post stroke; moderate‐severe weakness in their affected upper limbs, defined by the upper limb Fugl Meyer Motor Scale (score of 10‐35/66) Exclusion criteria: significant pain, instability or subluxation of the affected shoulder, severe elbow or wrist contractures, concurrent severe medical problems, cognitive dysfunction to the extent that would interfere with therapy participation, visual deficits, severe neglect or apraxia and current enrolment in ongoing upper limb therapy Mean (SD) age: intervention group 60 (10) years, control group 61 (13) years Stroke details: 50% ischaemic, 31% haemorrhagic, 19% unknown Timing post stroke: intervention group mean (SD) 65 (47) months, control group 67 (56) months |
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Interventions | VR intervention: Pneu‐WREX is a robotic device (4‐degree‐of‐freedom robot based on a passive arm support (WREX)). It is a lightweight exoskeleton that allows a wide ROM of the arm in a 3D space. The degrees of freedom are elbow flexion/extension, shoulder abduction/adduction, shoulder flexion/extension and shoulder forward/backward translation.The device can provide assistance as needed for a patient to actively participate and to be able to perform 3D tasks. Hand training through grasp and release is incorporated through a grip sensor that measures the pressure of a water‐filled cylinder bladder that the user holds, to detect even trace finger movement. A software package called Vu Therapy allowed for interface between the hardware and software. Tasks included grocery shopping, cleaning a window, playing basketball and driving a car. Auditory and visual feedback and a game score were provided to maintain attention and interest Control intervention: conventional exercises including ROM and task‐oriented movements Sessions were 60 min, 3 times/week for 8‐9 weeks (total = 24) for both groups |
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Outcomes | Outcomes assessed post intervention and 3 months following the end of intervention Arm Motor section of the Fugl Meyer Scale Rancho Functional Test for the hemiplegic UE Motor Activity Log Box and Blocks Test Grip strength (Jamar) Adverse events reported |
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Notes | Disclosure reported that the lead author has a financial interest in Hocoma, a company that makes robotic therapy devices | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded assessor |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported in detail |
Selective reporting (reporting bias) | Unclear risk | Unable to ascertain (does not mention protocol or trial registration) |