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

August 26, 2026 updated by: Christian Medical College and Hospital, Ludhiana, India

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • India
    • Punjab
      • Ludhiana, Punjab, India, 141008
        • Christian Medical College and Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years with ischemic or hemorrhagic stroke (one month to one year post stroke)
  2. 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.
  3. Cognitively able to follow instructions and provide informed consent (e.g., MMSE ≥ 24 or equivalent screening, or judged capable by the investigator).
  4. Access to a compatible smartphone and home internet service and willing/able to use the tele-rehab app.
  5. Skin at electrode application sites intact (no open wounds) and no dermatologic condition that would prevent safe application of the sleeve.

Exclusion Criteria:

  1. 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.
  2. Active seizure disorder (epilepsy) that is uncontrolled or where stimulation could increase seizure risk, diabetes mellitus.
  3. Pregnancy or breastfeeding.
  4. Known allergy to materials used in the FES sleeve or electrodes.
  5. Severe spasticity in target muscle groups (e.g., Modified Ashworth Scale ≥ 3) that prevents functional stimulation or safe participation.
  6. 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).
  7. Severe cognitive impairment, active psychiatric illness, or communication barriers that preclude safe device use or reliable consent/assessment.
  8. Open wounds, skin infection, severe dermatitis, or other skin conditions at electrode or sleeve contact sites.
  9. Participation in another interventional trial that would conflict with outcomes or safety reporting for this sub study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Home-Based FES
Participants will receive home-based FES for lower-limb rehabilitation for 12 weeks.
Device: Functional Electrical Stimulation (FES)
FES 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.
Active Comparator: Standard Rehabilitation
Participants will receive standard outpatient care and home-based rehabilitation without FES.
Other: Standard Rehabilitation
Participants will receive standard outpatient care and home-based rehabilitation without FES, with equivalent remote clinician contact and education.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Outcome Measure
Time Frame: Baseline 12 weeks
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.
Baseline 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Outcome
Time Frame: Baseline to 12 weeks.
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).
Baseline to 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Christian Medical College and Hospital, Ludhiana, India

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Indian Council of Medical Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr. Jeyaraj D Pandian, MD DM, Christian Medical College and Hospital, Ludhiana, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because the study protocol does not include a plan for sharing individual-level participant data. Study findings will be disseminated through scientific publications and presentations while protecting participant confidentiality and privacy.""Individual participant data will not be shared because the study protocol does not include a plan for sharing individual-level participant data. Study findings will be disseminated through scientific publications and presentations while protecting participant confidentiality and privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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