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

Hsieh 2011

Methods Pilot RCT
Methods of randomisation: by using a random‐number table, a sealed envelope was given to the therapists after a new eligible participant was registered, to deliver therapy accordingly
Participants Country: Taiwan
Sample size: 18 participants (6 in higher‐intensity robot‐assisted group, 6 in lower‐intensity robot‐assisted group, 6 in conventional rehabilitation group)
Inclusion criteria: unilateral stroke onset at least 6 months prior to study; an initial upper extremity subsection of the Fugl‐Meyer Assessment score of 30 to 56, indicating moderate to mild motor impairment; no excessive spasticity in elbow and wrist finger joints of the affected upper extremity (MAS < 3); ability to follow study instructions and perform study tasks (Mini‐Mental State Examination > 24); no upper limb fracture within 3 months; no participation in any experimental rehabilitation or drug studies during the study period; and written informed consent
Exclusion criteria: painful arthritis of the elbow, wrist, or finger joints; severe neuropsychologic impairments; physician‐determined major medical problems or poor physical condition that would interfere with participation; and cerebellar or brain stem lesions to limit potential interference of other symptoms or signs with task accomplishment
Interventions 3 groups:
  1. higher‐intensity RT group: Bi‐Manu‐Track used in this study for 20 training sessions for 90 to 105 minutes, 5 days per week for 4 weeks, within this group each participant practiced 600 to 800 repetitions of mode 1 (15 minutes), 600 to 800 repetitions of mode 2 (15 to 20 minutes), and 150 to 200 repetitions of mode 3 (5 minutes) for the forearm and wrist movement, after the RT participants received 15 to 20 minutes of functional activities training to help them transfer the acquired motor ability into ADL

  2. lower‐intensity RT group: with the Bi‐Manu‐Track the participants received over the same time a different frequency of 300 to 400 repetitions of mode 1 (15 minutes), 300 to 400 repetitions of mode 2 (15 to 20 minutes), and 70 to 100 repetitions of mode 3 (5 minutes) for the forearm and wrist movement, and after that they received the same treatment of functional abilities as the higher‐intensity group

  3. conventional rehabilitation group: these participants received a structured protocol using conventional occupational therapy techniques including passive range‐of‐motion exercises for 15 to 20 minutes, fine‐motor dexterity training for 20 minutes, gross‐motor training for 20 minutes, muscle strengthening of the affected upper limb for 15 to 20 minutes, activities of daily living for 15 to 20 minutes

Outcomes Outcomes were recorded at baseline and post‐treatment
  • FMA

  • MRC

  • MAL

  • ABILHAND scale to measure bimanual ability

Notes We combined the results of both the planar and the planar + vertical in 1 (collapsed) group and compared this collapsed group with the results of the control group
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk By random‐number table
Allocation concealment (selection bias) Low risk Sealed envelopes to accordingly deliver the intervention to the registered participant
Blinding of outcome assessment (detection bias) All outcomes Low risk All clinical measures were administered to the participants by the same blinded rater
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement