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Comparison of robotics, functional electrical stimulation, and motor learning methods for treatment of persistent upper extremity dysfunction after stroke: a randomized controlled trial |
McCabe J, Monkiewicz M, Holcomb J, Pundik S, Daly JJ |
Archives of Physical Medicine and Rehabilitation 2015 Jun;96(6):981-990 |
clinical trial |
7/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To compare response to upper-limb treatment using robotics plus motor learning (ML) versus functional electrical stimulation (FES) plus ML versus ML alone, according to a measure of complex functional everyday tasks for chronic, severely impaired stroke survivors. DESIGN: Single-blind, randomized trial. SETTING: Medical center. PARTICIPANTS: Enrolled subjects (n = 39) were > 1 year postsingle stroke (attrition rate 10%; 35 completed the study). INTERVENTIONS: All groups received treatment 5 d/wk for 5 h/d (60 sessions), with unique treatment as follows: ML alone (n = 11) (5 h/d partial- and whole-task practice of complex functional tasks), robotics plus ML (n = 12) (3.5 h/d of ML and 1.5 h/d of shoulder/elbow robotics), and FES+ML (n = 12) (3.5 h/d of ML and 1.5 h/d of FES wrist/hand coordination training). MAIN OUTCOME MEASURES: Primary measure: Arm Motor Ability Test (AMAT), with 13 complex functional tasks; secondary measure: upper-limb Fugl-Meyer coordination scale (FM). RESULTS: There was no significant difference found in treatment response across groups (AMAT p >= 0.584; FM coordination p >= 0.590). All 3 treatment groups demonstrated clinically and statistically significant improvement in response to treatment (AMAT and FM coordination: p <= 0.009). A group treatment paradigm of 1:3 (therapist/patient) ratio proved feasible for provision of the intensive treatment. No adverse effects. CONCLUSIONS: Severely impaired stroke survivors with persistent (> 1 y) upper-extremity dysfunction can make clinically and statistically significant gains in coordination and functional task performance in response to robotics plus ML, FES plus ML, and ML alone in an intensive and long-duration intervention; no group differences were found. Additional studies are warranted to determine the effectiveness of these methods in the clinical setting.
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