New functional electronic stimulation device for acute cerebrovascular disorder treatment: A preliminary prospective study.

Objective: Patients with cerebrovascular disease tend to exhibit patterned hemiplegia, such as the Wernicke-Mann posture. Delayed cessation of synkinesis is a major factor impeding hemiplegic recovery; however, effective rehabilitation for acute synkinesis has not been established. This study aimed to evaluate the efficacy and feasibility of a novel treatment using a low-frequency therapeutic device for the cessation of synkinesis in patients with incomplete paralysis and cerebrovascular disease.

Design: Single-arm, open-label study.

Subjects/patients: The study included patients aged ≥20 years with incomplete paralysis of the upper limbs, defined as Brunnstrom stage 2 to 4, within 1 month of a cerebrovascular accident.

Methods: Patients underwent rehabilitation using a low-frequency therapy device for daily joint movements. The primary outcome was the change from baseline in the Fugl-Meyer assessment (FMA) of upper limbs 2 weeks after treatment initiation (Trial registration: Japanese Clinical Registry, jRCTs05218022; date of registration: February 1, 2022). Ten patients with cerebrovascular disease participated in this study.

Results: The average duration was 6.4 ± 1.9 (range, 5.04-7.76) days, and the device caused no serious adverse events. Rehabilitation using this device significantly improved upper limb function. The FMA score was positively correlated with the Mini-Mental State Examination (r = 0.548, P = .101) and negatively with the FMA at the initial evaluation (r = -0.625, P = .054). The number of rehabilitation sessions was strongly correlated with the degree of improvement in the FMA (r = 0.432, P = .212).

Conclusion: This study demonstrated the use of low-frequency devices in the recovery of synkinesis in patients with cerebrovascular disease. However, this result requires verification in future large-scale, placebo-controlled studies.