Piron 2010
| Methods | RCT | |
| Participants | Recruited from a rehabilitation hospital in Rome, Italy 50 participants: 27 intervention, 23 control Inclusion criteria: single ischaemic stroke in the MCA territory > 6 months ago demonstrated by CT or MRI, received conventional physiotherapy early after stroke, mild to intermediate motor impairments of the arm (score of 20 to 60 on the Fugl Meyer UE Scale) Exclusion criteria: clinical history or evidence of cognitive impairments, neglect, apraxia or aphasia interfering with verbal comprehension Mean (SD) age: intervention group 59 (8) years, control group 62 (10) years 58% male Stroke details: 58% right hemiparesis Timing post stroke: intervention group mean 15 (13) months, control group 15 (12) months |
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| Interventions | Virtual reality intervention: participants were asked to perform motor tasks with real objects (for example an envelope or a glass), which were displayed as tasks within the virtual environment (for example putting an envelope in the mailbox, breaking eggs, moving a glass over a table, placing a ball in a basket). A 3D magnetic receiver was used to record the motions. Participants were asked to emulate the tasks as per the therapist's pre‐recorded movement Control intervention: participants were asked to perform specific exercises for the arm, for example touching different targets, manipulating objects and following trajectories on a plan Sessions were 60 minutes, 5 times a week for 4 weeks (20 hours total) |
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| Outcomes | Outcomes recorded at baseline and post‐intervention Upper limb function and activity outcomes (arm): Fugl Meyer UE Scale Activity limitation outcomes: Functional Independence Measure Adverse events reported |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Personal correspondence with the author reports the use of a simple computer‐generated sequence |
| Allocation concealment (selection bias) | Low risk | Sequentially numbered, opaque, sealed envelopes |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blind |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis was completed. In the case of missing data the authors used a 'best, worst and likely' approach to data imputation. There was a small amount of attrition and the reasons for this were reported |
| Selective reporting (reporting bias) | Low risk | No other outcomes were collected |