Background: Stroke often leads to motor function impairment, necessitating long-term rehabilitation. Functional electrical stimulation (FES) is a promising treatment for foot drop and can be effectively utilized in home settings with wearable devices. This study evaluated the feasibility and acceptability of a home-based FES intervention, both alone and integrated with a behavioral implementation intention (II) intervention, in enhancing physical function among stroke patients, compared to a control group.
Method: Stroke patients, within 5 years post-stroke and with impaired ankle voluntary movement, were randomly assigned to one of three groups: (1) home-based FES training with walking for at least 1 hour per day for 2 months; (2) FES combined with II, which involved forming specific if-then action and coping plans for daily FES training, developed through focus groups and reinforced with two follow-up phone calls; (3) a control group receiving upper limb exercise training. Recruitment, randomization, and retention rates were documented. Secondary outcomes, including walking speed, balance, and adherence, were measured at baseline, and 0, 2, and 4 months post intervention. Qualitative interviews were conducted at the end of the trial.
Results: The study successfully recruited and retained 16 participants within two months, with no major issues in intervention delivery and no baseline differences across groups. Generalized estimating equations will be used to assess the preliminary efficacy of the interventions.
Conclusions: The feasibility of this three-arm trial was preliminarily supported, and the results will inform the design of a larger trial. Both the combined intervention group and the home-based FES intervention alone group are expected to demonstrate superior physical function outcomes compared to the control group.


Trial registration: UMIN no. UMIN000056247