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. 2015 Nov 7;2015(11):CD006876. doi: 10.1002/14651858.CD006876.pub4

Klamroth‐Marganska 2014

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
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
Interventions 2 groups:
  1. robotic therapy with ARMin, each of 3 therapy modes (mobilisation, games, and training for activities of daily living) had to be done for at least 10 minutes

  2. conventional therapy: receiving common neurorehabilitation treatment given to participants after stroke in outpatient facilities, namely occupational therapy or physiotherapy. Therapists were asked to give regular therapy, usually including mobilisation, games, activities of daily living, or any combination of the 3


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
Outcomes Outcomes were recorded at baseline and post‐treatment every 2 weeks
  • FMA

  • WMFT

  • quality of movement section of the MAL

  • Stroke Impact Scale (SIS 2.0)

  • Goal Attainment Scale

  • MAS

  • grip strength (handheld dynamometer)

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