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

Burgar 2011

Methods Prospective, single‐blinded RCT Method of randomisation: stratified random number table
Participants Country: USA
Sample size: 54 participants (19 in the first treatment group, 17 in the second treatment group, and 18 in the control group)
Inclusion criteria: primary diagnosis of stroke
Exclusion criteria: people were excluded if they exhibited upper limb joint pain that restricted normal movement, had absent proprioception at the elbow or shoulder joints, or scored less than 22 on the Mini Mental State Examination. People with cardiovascular, orthopaedic, or neurological conditions that would have precluded exercise in short‐duration, moderate‐workload trials were also excluded
Interventions 3 groups:
  1. Robot‐Lo: received up to 15 1‐hour therapy sessions over a 3‐week period with the MIME system

  2. Robot‐Hi: received up to 30 1‐hour therapy sessions over a 3‐week period with the MIME system

  3. Control group: received up to 15 1‐hour therapy sessions over a 3‐week period

Outcomes Outcomes were recorded at baseline, just after completion of training (after 3 weeks), and 6 months later (follow‐up)
  • FMA (maximum 66 points)

  • FIM (upper limb, maximum 63 points)

  • Motor Power (maximum 70*)

  • Ashworth (MAS maximum 5 points)

  • WMFT Functional Ability Scale (maximum 5 and time in seconds)


*The strength of 14 shoulder and elbow muscle groups was assessed by performing manual muscle testing of isolated joint actions and applying the MRC Motor Power grading scale (0 to 5) with a maximum possible score of 70 (scapular abduction/upward rotation, scapular elevation, adduction, adduction/depression, adduction/downward rotation, flexion, extension, abduction, horizontal adduction, horizontal abduction, external rotation, internal rotation, elbow flexion, elbow extension)
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random‐number table
Allocation concealment (selection bias) Unclear risk Unclear, not reported
Blinding of outcome assessment (detection bias) All outcomes Low risk A second therapist at each site, blinded to group assignment, performed a clinical assessment battery just before study initiation, just after completion of training, and again at the 6‐month follow‐up
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement