Klamroth‐Marganska 2014.
Methods | RCT | |
Participants | 77 participants: 39 VR group, 38 control group Recruited from 4 clinical settings in Switzerland Main inclusion criteria: diagnosis of 1, first ever cerebrovascular accident verified by brain imaging (MRI or CT); chronic impairment after stroke (minimum 6 months); moderate‐severe arm paresis, as indicated by a score of 8‐38 on arm section of Fugl‐Meyer assessment (which has a maximum of 66 points); aged ≥ 18 years; able to sit in a chair without any additional support and without leaning on the back rest; passive ROM in the shoulder as assessed with the neutral zero method: anteversion/retroversion 80°/0°/20°, abduction/adduction 60°/0°/10°, inner and outer rotation 20°/0°/20°; passive ROM in the elbow as assessed with the neutral zero method; flexion/extension 100°/40°/40°; no excessive spasticity of the affected arm (modified Ashworth Scale ≤ 3); no serious medical or psychiatric disorder as assessed by their physician; no cybersickness (nausea when looking at a screen or playing computer games); no pacemaker or other implanted electric devices; bodyweight < 120 kg; no serious cognitive defects or aphasia Mean age (SD): intervention group 55 (13), control group 58 (14) years 60% men Timing post stroke: mean (SD) 52 (44) months intervention group, 40 (45) months control group |
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Interventions | VR intervention: during the robotic therapy with ARM in, each of 3 therapy modes (mobilisation, games, and training for ADL) had to be done for ≥ 10 min Control intervention: common neurorehabilitation treatment given to patients after stroke in outpatient facilities, namely OT or physiotherapy. Therapists were asked to give regular therapy, usually including mobilisation, games, ADL, or any combination of the 3. Their only restriction was not to use automated technical devices that might be available in therapy settings. For both groups, therapy was given 3 times/week in the centres for a period of 8 weeks (total 24 sessions) and sessions were ≥ 45 min |
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Outcomes | Outcomes assessed 3‐4 weeks before assignment, immediately before therapy (baseline), after 4 weeks of therapy, at the end of 8 weeks of therapy, and 16 weeks and 34 weeks after baseline Upper limb function: Fugl Meyer UE, Wolf Motor Function Test, Motor Activity Log (quality of movement) Quality of life and participation: Stroke Impact Scale, Goal attainment scale Adverse events reported |
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Notes | NCT00719433 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated list |
Allocation concealment (selection bias) | Low risk | Tamper‐evident envelopes |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessors were masked to treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Few withdrawals. ITT analysis conducted |
Selective reporting (reporting bias) | Low risk | Registered on clinical trial |