Coupar 2012

Methods	RCT
Participants	Recruited from a stroke unit in Glasgow, UK 12 participants: 4 high intensity intervention, 4 low intensity intervention, 4 control Inclusion criteria: ≥ 18 years with a clinical diagnosis of stroke and grade 1 to 4 on MRC scale of arm impairment. Medically stable and within 10 days post stroke. Able to give informed consent, understand and follow simple instruction and sitting balance sufficient to use the device safely Exclusion criteria: orthosis could not be fitted to the affected limb due to previous stroke or other condition, bone instability of affected upper limb, no functional use of affected upper limb due to previous stroke or other condition. Pronounced fixed contractures of affected upper limb, open skin lesions on affected upper limb; major sensory deficit of affected upper limb; shoulder instability or excessive pain; severe spasticity; severe spontaneous movements; confused or non‐co‐operative; isolation due to infection; visual, perceptual or cognitive problems precluding participation in study involvement or involvement in any other intervention study Mean (SD) age: high intensity intervention group 65 (14), low intensity 72 (10), control 59 (16) 66% male Stroke details: 42% right hemiparesis Timing post stroke: high intensity intervention 8 (1) days, low intensity 9 (2), control 8 (3)
Interventions	Virtual reality intervention: Low intensity: standard care plus Armeo®Spring arm orthosis and virtual reality games for arm rehabilitation used for 40 minutes per day, 3 days a week High intensity: standard care plus Armeo®Spring arm orthosis and virtual reality games for arm rehabilitation used for 60 minutes per day, 5 days a week Games included catching rain drops, picking apples and cleaning a cooker Control intervention: standard care including standard physiotherapy and occupational therapy targeted at arm recovery Sessions were for 2 weeks or until discharge from the stroke unit (whichever was soonest)
Outcomes	Outcomes recorded at baseline, completion of intervention and 3 months following completion Upper limb function: Action Research Arm Test, Fugl Meyer UE Activity restriction: Barthel Index Other outcomes related to feasibility, acceptability, safety, arm pain, perceived exhaustion and adverse events
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated sequence
Allocation concealment (selection bias)	Low risk	Sealed, numbered, opaque envelopes
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinded to allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	Few withdrawals and balanced across groups for reasons not clearly related to the study
Selective reporting (reporting bias)	Low risk	All outcomes reported in thesis