Methods | RCT Methods of randomisation: computer‐generated list of random numbers was used that paired a unique sequential number with a treatment type (robotic or conventional). Pairs were sealed in tamper‐evident envelopes by the study co‐ordinator |
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Participants | Country: Switzerland Sample size: 77 Inclusion criteria: diagnosis of 1, first‐ever cerebrovascular accident verified by brain imaging (magnetic resonance imaging or computed tomography); chronic impairment after stroke (minimum 6 months); moderate to severe arm paresis as indicated by a score of 8 to 38 on arm section of FMA (which has a maximum of 66 points); aged ≥ 18 years; stable recovery stage; able to sit in a chair without any additional support and without leaning on the back rest; passive range of motion 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 range of motion in the elbow as assessed with the neutral zero method: flexion/extension 100°/40°/40° Exlusion criteria: excessive spasticity of the affected arm (MAS ≤ 3); serious medical or psychiatric disorder as assessed by their physician; participation in any clinical investigation within previous 4 weeks; participation in any therapeutic treatment (apart from assigned therapy) done with the paretic arm during the therapy phase of the study; anticipated need for any major surgery during the study; pregnancy or breastfeeding; orthopaedic, rheumatological, or other disease restricting movements of therapeutic arm; shoulder subluxation (palpation < 2 fingers); skin ulcerations at the paretic arm; not able to communicate effectively with the examiner such that the validity of the participant’s data could not be compromised; cyber sickness (e.g. nausea when looking at a screen or playing computer games); pacemaker or other implanted electric devices; bodyweight above 120 kg; serious cognitive defects or aphasia preventing effective use of ARMin |
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Interventions | 2 groups:
Therapy was given 3 times a week for a period of 8 weeks (sum of 24 sessions). Minimum session time (excluding time for preparation, diagnostics, and documentation) was 45 minutes |
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Outcomes | Outcomes were recorded at baseline and post‐treatment every 2 weeks
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "computer‐generated list of random numbers was used, which paired a unique sequential number with a treatment type (robotic or conventional)" |
Allocation concealment (selection bias) | Low risk | Quote: "Pairs were sealed in tamper‐evident envelopes by the study co‐ordinator." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Assessors were masked to treatment allocation" |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |