Home-Based Functional Electrical Stimulation for Lower Limb Rehabilitation in Stroke Patients.

Stroke is a major cause of long-term disability and frequently results in impaired lower-limb motor function, reduced walking ability, and limitations in independent mobility. Although functional electrical stimulation (FES) is an established rehabilitation approach for activating peripheral nerves and muscles to facilitate functional movement, conventional FES-based rehabilitation is often delivered in clinical settings and may require repeated supervision, accurate electrode placement, and technical assistance. These requirements can limit access to rehabilitation, particularly for individuals who have difficulty attending frequent outpatient sessions.

This study will investigate the feasibility of delivering FES as a home-based rehabilitation intervention supported by a smartphone-based telerehabilitation platform. The project incorporates development and clinical evaluation of an indigenous FES system designed for home use. The system is being developed with features intended to support safe and independent use, including IoT-enabled monitoring of device use and an ECG-based heart-rate monitoring component. The accompanying smartphone platform is intended to facilitate remote training, clinician follow-up, adherence monitoring, safety monitoring, and troubleshooting.

Condition The study will include adults recovering from stroke, including ischemic and hemorrhagic stroke, with lower-limb motor impairment. The study focuses on post-stroke lower-limb dysfunction and limitations in functional walking ability.

Study Design This is an assessor-blinded, randomized, parallel-group, active-controlled feasibility trial. The study will be conducted at two sites within the INSTRUCT Network in India. Eligible participants will be randomly allocated to either the home-based FES intervention or standard rehabilitation. Outcome assessment will be performed by assessors who are blinded to treatment allocation where feasible.

The project consists of two broad phases. The first phase involves development and validation of the home-based FES system at IIT Kharagpur. The development process includes engineering of the stimulation system, incorporation of safety and monitoring components, laboratory/bench validation, and preparation of units for clinical evaluation. The second phase involves implementation of the feasibility randomized controlled trial at participating clinical sites.

Before home use, participants allocated to the FES group will undergo structured training to establish safe and competent operation of the device. Training will include device orientation, electrode-placement instruction, safety procedures, supervised practice, and competency verification. The smartphone-based platform will support remote supervision and monitoring during the home-use period.

The feasibility study is intended primarily to establish whether the intervention can be delivered safely and practically in a home setting and whether participants can use the technology with limited direct clinical assistance. Information generated from recruitment, retention, adherence, safety, device usability, and preliminary functional outcomes will be used to refine the intervention and study procedures and to inform the design and sample-size planning of a subsequent fully powered randomized controlled trial.

The study also provides an opportunity to evaluate the integration of rehabilitation technology, remote clinical support, and home-based FES delivery within the Indian stroke rehabilitation setting. If feasibility criteria are met, the findings may support further evaluation and potential wider implementation of technology-enabled home rehabilitation for people with post-stroke disability.

Inclusion criteria

• 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.
• Skin at electrode application sites intact (no open wounds) and no dermatologic condition that would prevent safe application of the sleeve.

Exclusion criteria

• 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.
• Severe spasticity in target muscle groups (e.g., Modified Ashworth Scale ≥ 3) that prevents functional stimulation or safe participation.
• Severe cardiovascular instability or uncontrolled medical conditions that make participation unsafe (e.g., unstable angina, recent myocardial infarction within 3 months, uncontrolled hypertension-systolic >180 mmHg or diastolic >110 mmHg at screening).
• Severe cognitive impairment, active psychiatric illness, or communication barriers that preclude safe device use or reliable consent/assessment.
• Open wounds, skin infection, severe dermatitis, or other skin conditions at electrode or sleeve contact sites.
• Participation in another interventional trial that would conflict with outcomes or safety reporting for this sub study.