Saposnik 2016.
Methods | RCT | |
Participants | Recruited from rehabilitation units in 4 countries: Canada, Argentina, Peru, Thailand 141 participants: 71 intervention group, 70 control group Inclusion criteria: 18‐85 years with first time ischaemic stroke within 3 months of enrolment and with mild to moderate motor disability (Chedoke McMaster Stroke Assessment stage > 3) Exclusion criteria: no disability in the UE (arm components of the Chedoke McMaster scale = 7), were unable to follow instructions, pre‐stroke Modified Rankin score of ≥ 2, medically unstable or uncontrolled hypertension; severe illness with a life expectancy of < 3 months, unstable angina or MI within 3 months, history of seizures or epilepsy (except for febrile seizures of childhood); participating in another clinical trial involving an investigational drug or physical therapy or had any condition that might put the patient at risk (e.g. known shoulder subluxation) Mean (SD) age: intervention group 62 (13) years, control group 62 (12) years Stroke details: 100% ischaemic; right hemiparesis 47% Timing post stroke: intervention group mean 27 d, control group mean 24.5 d |
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Interventions | VR intervention: Nintendo Wii Sports and Game Party 3. Progression through the intervention allowed participants to choose some specific activities within those games (last 3 min of the intervention) based on their capabilities and interest with the goals of enhancing flexibility, ROM, strength and co‐ordination of the affected arm Control intervention: recreational therapy with progression through activities such as cards, bingo, Jenga or a ball game Administered 1:1 by a rehabilitation therapist Sessions were 60 min, 5 times/week for 2 weeks |
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Outcomes | Outcomes were recorded at 2 weeks (post intervention) and 4 weeks Abbreviated Wolf Motor Function Test Box and Block Test Quality of life after stroke ‐ Stroke Impact Scale Functional Independence Measure, Barthel Index, Modified Rankin Scale Grip strength (dynamometer) Hand function ‐ Stroke Impact Scale Adverse events reported |
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Notes | NCT01406912 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated assignment |
Allocation concealment (selection bias) | Low risk | Assignment at the point enrolment |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded assessor |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis conducted. Details of withdrawals reported transparently |
Selective reporting (reporting bias) | Low risk | All outcomes reported |