This assessor-blinded, randomized, parallel-group feasibility trial will evaluate the feasibility and preliminary effectiveness of a home-based Functional Electrical Stimulation (FES) system for lower-limb rehabilitation in adults recovering from stroke. The study will be conducted at two sites within the INSTRUCT Network in India.
Adults aged 18 years or older who are 1 month to 1 year post-stroke and have mild to moderate lower-limb weakness will be eligible to participate. A total of 70 participants will be randomly allocated in a 1:1 ratio to either a home-based FES intervention group or a control group receiving standard rehabilitation.
Participants in the FES group will receive training on safe and independent use of the FES device before commencing home treatment. FES will be delivered to selected lower-limb muscles, including the quadriceps, tibialis anterior, and hamstrings, for 30 minutes per session, 5 sessions per week, for 12 weeks. The intervention will be supported by a smartphone-based telerehabilitation platform that will provide remote clinician support, training, adherence monitoring, and troubleshooting. The FES system is being developed with IoT-enabled monitoring and ECG-based heart-rate safety monitoring to facilitate safe home use.
Participants in the control group will receive standard outpatient care and home-based rehabilitation without FES. Both groups will receive equivalent remote clinician contact and education.
The primary purpose of the study is to determine the feasibility of home-based FES, including recruitment, retention, adherence to prescribed treatment sessions, safety, and participants' ability to independently operate the device at home. Secondary evaluation will assess preliminary changes in functional walking ability using the 6-Minute Walk Test (6MWT), measured at baseline and after 12 weeks.
The study is intended to generate feasibility and preliminary effectiveness data to inform the design of a future, adequately powered randomized controlled trial and to assess the potential for wider implementation of home-based FES rehabilitation for people recovering from stroke.
Age ≥ 18 years with ischemic or hemorrhagic stroke (one month to one year post stroke)
Clinical evidence of mild to moderate lower-limb weakness, defined as Manual Muscle Test (MMT) grade 2 or 3 in one or more target muscle groups (e.g., tibialis anterior, quadriceps, hamstrings) on the affected side.
Cognitively able to follow instructions and provide informed consent (e.g., MMSE ≥ 24 or equivalent screening, or judged capable by the investigator).
Access to a compatible smartphone and home internet service and willing/able to use the tele-rehab app.
Implanted electronic medical device contraindicated with FES (e.g., pacemaker, implantable cardioverter-defibrillator) or other metallic implants near stimulation site that the treating clinician deems a contraindication.
Active seizure disorder (epilepsy) that is uncontrolled or where stimulation could increase seizure risk, diabetes mellitus.
Pregnancy or breastfeeding.
Known allergy to materials used in the FES sleeve or electrodes.
Parallel
Functional Electrical Stimulation (FES)
DeviceFES will be applied to the quadriceps, tibialis anterior, and hamstrings for 30 minutes per session, 5 sessions per week, for 12 weeks, supported by a smartphone-based telerehabilitation platform for training, adherence monitoring, safety monitoring, and remote clinician support.
Standard Rehabilitation
Other interventionParticipants will receive standard outpatient care and home-based rehabilitation without FES, with equivalent remote clinician contact and education.
6-minute walk test (6MWT)
The primary outcome of this study is 6MWT, a validated measure of functional walking endurance and lower limb mobility in stroke survivors. Participants will be instructed to walk at their usual pace along a flat, unobstructed path for six minutes, with total distance covered recorded in meters. The 6 MWT will be conducted at baseline and at the end of the intervention period after 12 weeks.
Recruitment rate
Recruitment will be assessed as the proportion of eligible participants who consent to participate in the study. The numbers approached, screened, eligible and enrolled will be recorded. Each site will aim to recruit an average of 1 or 2 participants per month.
Adherence rate
Adherence rate will be calculated as the number and proportion of prescribed sessions attended by each participant. We anticipate that 80 percent of participants will complete the total scheduled sessions.
Retention rate
Retention rate proportion of participants who complete the study through final assessment point to meet or exceed the minimal acceptable level of 85 percent across the full study duration.
Independent Use Ability
The feasibility of independent home-based FES use will be assessed by determining whether participants can safely and correctly don, operate, and remove the FES without direct clinician assistance. This will be monitored through observation during initial training sessions (video-supervised), self-reported ease of use using 5-point Likert scale, platform logs confirming successful device activation and completion of stimulation cycles and number of remote troubleshooting contacts required during the study. It will include total minutes of active FES use, average duration per session, and proportion of sessions in which the device was used as prescribed. An acceptable device usage rate will be defined as participants engaging in \>75% of the expected device on-time across all scheduled sessions.
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Christian Medical College and Hospital, Ludhiana, India
Lead sponsor
Indian Council of Medical Research
Collaborator
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