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Pilot randomized controlled trial of self-regulation in promoting function in acute post-stroke patients
Liu KPY, Chan CCH
Archives of Physical Medicine and Rehabilitation 2014 Jul;95(7):1262-1267
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To test the efficacy of self-regulation for promoting task performance and motor and cognitive functions. DESIGN: Pilot randomized controlled trial. SETTING: An in-patient rehabilitation stroke unit. PARTICIPANTS: Forty-four acute post-stroke in-patients aged >= 60 years after a cerebral infarction. INTERVENTIONS: The patients were randomly assigned to the self-regulation (n = 24) or functional rehabilitation (control) (n = 20) intervention. The self-regulation intervention consisted of 1-week of therapist-supervised practices of daily tasks using self-reflection of one's own performance (5 one-hour sessions). Patients in the control intervention practiced the same daily tasks with a therapist's demonstration and guidance. MAIN OUTCOME MEASURES: Performance of tasks including household and monetary transaction tasks; Functional Independence Measure; Fugl-Meyer Assessment; Color Trails Test. RESULTS: The self-regulation group showed significant improvement in all tasks (median diff 1.0 to 2.0; effect size (r) = 0.74 to 0.89) versus none (median diff 0 to 0.5) in the control group. Results of the Functional Independence Measure (p < 0.001, r = 0.87 in motor subscale; p < 0.001, r = 0.49 in cognitive subscale), Fugl-Meyer Assessment (p < 0.001, r = 0.84 and 0.63) and Color Trails Test (p = 0.002, r = 0.72) of the self-regulation group improved. The self-regulation group outperformed their control counterparts in 4 of the 5 tasks (median diff 1.0; r = 0.30 to 0.52)) and in the Functional Independence Measure motor subscale (p = 0.002, r = 0.47), but not in the cognitive subscale, motor and cognitive functions. CONCLUSIONS: Self-regulation appears useful for improving task performance that demands both motor and cognitive abilities by promoting information processing and active learning.

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