Home-Based Functional Electrical Stimulation for Lower Limb Rehabilitation in Stroke Patients. | NCT07785700 | Trialant

Not yet recruitingInterventionalNot ApplicableUpdated Aug 25, 2026

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

Feasibility and Effectiveness of Home-Based Functional Electrical Stimulation (FES) for Lower Limb Rehabilitation in Post-Stroke Individuals

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07785700
Lead Sponsor: Christian Medical College and Hospital, Ludhiana, IndiaOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 70Estimated
Last Update Posted: Aug 25, 2026Actual
Start Date: Jan 1, 2027Estimated
Primary Completion Date: Dec 31, 2030Estimated
Completion Date: Dec 31, 2030Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Feasibility and Effectiveness of Home-Based Functional Electrical Stimulation (FES) for Lower Limb Rehabilitation in Post-Stroke Individuals
Brief Summary: 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.

Conditions

The medical conditions and diseases this study investigates.

Stroke

Interventions

The treatments and procedures being evaluated in this study.

Functional Electrical Stimulation (FES)
Standard Rehabilitation

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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.

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts

The people to reach with questions about this study or how to join it.

Dr. Jeyaraj D Pandian, MD DMContact

jeyarajpandian@hotmail.com+91 9915784750

Locations

Where the study is run and whether each site is currently recruiting.

Christian Medical College and Hospital

Ludhiana, Punjab 141008, India

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Christian Medical College and Hospital, Ludhiana, IndiaOTHER
Collaborators

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Other registered studies that closely resemble this one.

Detailed Description

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.