TOPLINE:

Contralaterally controlled functional electrical stimulation (CCFES) was associated with greater reduction in upper extremity impairment compared with conventional cyclic neuromuscular electrical stimulation (cNMES) or task-oriented training (TOT) — and with improved upper limb function vs TOT — in stroke survivors with chronic hand hemiparesis, a new phase 2 trial showed. However, compared to the other two treatments, CCFES was not linked to better improvement in manual dexterity, which was the primary outcome.

METHODOLOGY:

• A phase 2, multisite, three-arm parallel group trial was conducted from 2019 to 2024 and included more than 100 participants who had hemorrhagic or ischemic stroke 6-24 months previously and unilateral upper extremity hemiparesis.
• Participants were randomly assigned to receive CCFES (n = 36; mean age, 59 years; 64% men), cNMES (n = 39; mean age, 59 years; 56% men), or TOT (n = 38; mean age, 61 years; 76% men). CCFES involved the use of an instrumented glove worn on the contralateral hand to proportionally control stimulation of the paretic hand and cNMES involved delivery of automatic cyclic stimulation. TOT included training without electrical stimulation.
• The treatment protocol included 10 sessions per week of self-administered treatment-specific exercises at home and 22 functional task practice sessions in the laboratory for 12 weeks.
• The primary outcome was change in Box and Blocks test (BBT) scores from baseline to 6 months post-treatment to assess manual dexterity. Secondary outcomes included upper extremity Fugl-Meyer assessment; the action research arm test to measure functional ability; and responder rates.

TAKEAWAY:

• Participants in all three groups showed significant improvements in BBT scores by 6 months post-treatment, but between-group differences were not statistically significant.
• Upper extremity Fugl-Meyer score gains were higher for the CCFES group compared to the cNMES (P = .003) and TOT (P = .01) groups, and functional ability score gains were significantly greater for the CCFES group than the TOT group (P = .008).
• Responder rates based on upper extremity scores 6 months post-treatment were greater for CCFES (67%) than cNMES (42%; P = .047) and TOT (38%; P = .02). There were no between-group differences in responder rates based on changes in BBT (27% vs 32% and 21%, respectively) or functional ability scores (42% vs 32% and 26%, respectively).
• No serious treatment-related adverse events were reported.

IN PRACTICE:

The investigators noted that this was the first multisite clinical trial of CCFES to be published.

“Overall, the findings suggest that CCFES, a mechanistically based high-dose rehabilitation task practice therapy that includes a home component that patients can self-administer with easy-to-use portable technology, can facilitate hand motor recovery, even in individuals with chronic moderate-to-severe hand function deficits,” they wrote.

SOURCE:

The study was led by Jayme S. Knutson, PhD, MetroHealth Rehabilitation Institute, Cleveland. It was published online on November 13 in Stroke.

LIMITATIONS:

Only 79%-87% of participants per group completed the 6‑month assessment, which may have produced false negatives. The lack of blinding of participants and therapists may have introduced bias or crossovers. Additionally, imaging data were unavailable to confirm stroke types or lesion locations. The results were not generalizable to patients who had a stroke less than 6 months or more than 2 years previously, those with severe spasticity preventing stimulated hand opening, or those with hemiparesis due to other neurologic conditions.

DISCLOSURES:

This study was funded by the National Center for Medical Rehabilitation Research. Knutson and another investigator reported being co-inventors on the CCFES patent. Several other researchers reported financial or other ties with various organizations. Full details are provided in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.