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Electrically assisted movement therapy in chronic stroke patients with severe upper limb paresis: a pilot, single-blind, randomized crossover study
Carda S, Biasiucci A, Maesani A, Ionta S, Moncharmont J, Clarke S, Murray MM, Millan JR
Archives of Physical Medicine and Rehabilitation 2017 Aug;98(8):1628-1635
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 evaluate the effects of electrically assisted movement therapy (EAMT) in which patients use functional electrical stimulation, modulated by a custom device controlled through the patient's unaffected hand, to produce or assist task-specific upper limb movements, which enables them to engage in intensive goal-oriented training. DESIGN: Randomized, crossover, assessor-blinded, 5-week trial with follow-up at 18 weeks. SETTING: Rehabilitation university hospital. PARTICIPANTS: Patients with chronic, severe stroke (n = 11; mean age 47.9y) more than 6 months poststroke (mean time since event 46.3mo). INTERVENTIONS: Both EAMT and the control intervention (dose-matched, goal-oriented standard care) consisted of 10 sessions of 90 minutes per day, 5 sessions per week, for 2 weeks. After the first 10 sessions, group allocation was crossed over, and patients received a 1-week therapy break before receiving the new treatment. MAIN OUTCOME MEASURES: Fugl-Meyer Motor Assessment for the Upper Extremity, Wolf Motor Function Test, spasticity, and 28-item Motor Activity Log. RESULTS: Forty-four individuals were recruited, of whom 11 were eligible and participated. Five patients received the experimental treatment before standard care, and 6 received standard care before the experimental treatment. EAMT produced higher improvements in the Fugl-Meyer scale than standard care (p < 0.05). Median improvements were 6.5 Fugl-Meyer points and 1 Fugl-Meyer point after the experimental treatment and standard care, respectively. The improvement was also significant in subjective reports of quality of movement and amount of use of the affected limb during activities of daily living (p < 0.05). CONCLUSIONS: EAMT produces a clinically important impairment reduction in stroke patients with chronic, severe upper limb paresis.

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