Eric C Leuthardt, Seth J Wilk, Lauren Souders, Kelly B Carr, Robert Coker, Gregory E Wilding, Dorothee Zuleger, Benjamin T Acland, Alexandre R Carter
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引用次数: 0
Abstract
Background: At-home stroke rehabilitation methods have strong potential to supplement limited clinical resources, but realizing that potential for survivors in the chronic phase of recovery requires developing and validating more effective options than the home exercise programs typically used today. BCI-REHAB (At-Home BCI Rehabilitation Therapy for Chronic Upper Extremity Deficit After Stroke) compared an at-home brain-computer interface (BCI) therapy system (IpsiHand System) versus an at-home exercise program for improving upper extremity function in patients with chronic hemiparetic stroke.
Methods: Participants aged 18 to 85 years with a history of stroke ≥6 months before enrollment and right or left upper extremity paresis or plegia were screened and randomly assigned to either an at-home exercise program or to a BCI electroencephalogram system coupled to a range-of-motion assist handpiece. Participants completed 12 weeks of at-home therapy (5 sessions per week). The primary outcome was the change in the Upper Extremity Fugl-Meyer Assessment from baseline to 12 weeks.
Results: Overall, 109 participants were assessed for eligibility; 85 met the inclusion criteria and were randomized (43 intervention, 42 control). Of the 42 control participants, n=17 declined to participate further due to dissatisfaction with study arm assignment. A total of 62 participants were analyzed for the primary outcome (37 intervention, 25 control). The primary outcome (mean change) was significantly higher in the BCI group (6.0 [95% CI, 3.9-8.1]; P<0.0001) versus the control group (1.5 [95% CI, -0.1 to 3.1]; P=0.07), with an estimated treatment difference of 4.5 ([95% CI, 1.9-7.1]; P=0.0007). Participants who received the BCI intervention showed an estimated response rate of 55.5% (95% CI, 33.7%-77.2%), compared with 9.6% (95% CI, -2.9% to 22.1%) in the control group. This corresponds to an absolute increase in response of 45.8% ([95% CI, 20.9%-70.8%]; P=0.0003), yielding a number needed to treat of 2.2.
Conclusions: At-home BCI therapy provides clinically meaningful improvement in upper extremity function for chronic stroke survivors compared with standard at-home exercise programs.
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