Contralaterally Controlled Functional Electrical Stimulation for Upper Extremity Recovery Following Stroke: A...

This study compared the effects of contralaterally controlled functional electrical stimulation (CCFES) to cyclic neuromuscular electrical stimulation (cNMES) and task-oriented training (TOT) without electrical stimulation (TOT) on the recovery of hand function in stroke survivors with chronic hand hemiparesis.

In this assessor-blinded randomized controlled trial conducted at 4 sites in the United States, individuals 6 to 24 months poststroke with moderate-to-severe hand weakness were randomly assigned 1:1:1 to CCFES, cNMES, or TOT and prescribed 10 sessions/week of treatment-specific exercise at home plus 22 sessions of treatment-specific functional task practice in the laboratory over 12 weeks. The primary outcome was the change in the box and blocks test score at 6 months after treatment. Secondary measures included the upper extremity Fugl-Meyer, the action research arm test, and responder rates. Mixed effects analyses and differences of least square means were used to evaluate treatment effects.

Between February 15, 2019, and January 24, 2024, 132 patients were randomized; 113 completed the treatment phase (36 CCFES, 39 cNMES, and 38 TOT) and were included in the analysis (modified intention-to-treat). There were no significant between-group differences in the change in the box and blocks test score at 6 months after treatment. CCFES improved upper extremity Fugl-Meyer scores more than cNMES and TOT, CCFES versus cNMES difference of 4.4 (95% CI, 1.5-7.3; P=0.003), and CCFES versus TOT difference of 3.7 (95% CI, 0.8-6.5; P=0.012). CCFES improved action research arm test scores more than TOT, CCFES versus TOT difference of 4.1 (95% CI, 1.1-7.1; P=0.008). The responder rate based on an increase in upper extremity Fugl-Meyer ≥5.25 points at 6 months after treatment was greater for CCFES than cNMES (67% versus 42%; P=0.047) and TOT (67% versus 38%; P=0.020). There were no between-group differences in responder rates based on the box and blocks test (27% CCFES, 32% cNMES, and 21% TOT) or action research arm test (42% CCFES, 32% cNMES, and 26% TOT). There were no serious treatment-related adverse events.

By 6 months after 12 weeks of treatment, CCFES did not improve dexterity more than cNMES or TOT. CCFES reduced upper extremity impairment more than cNMES and TOT and improved upper limb function more than TOT.

URL: https://www.clinicaltrials.gov; Unique Identifier: NCT03574623.