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StrokeFESNCT07785700

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

A study testing Functional Electrical Stimulation (FES) and Standard Rehabilitation in people with Stroke, run by Christian Medical College and Hospital, Ludhiana, India at 3 sites in India.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Stroke
What is being tested?
Functional Electrical Stimulation (FES) and Standard Rehabilitation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
3 sitesIndia
Study dates
1 Sep 2026to 30 Aug 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 9Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dr. Jeyaraj D Pandian, MD DM contact

+91 9915784750

jeyarajpandian@hotmail.com

India3 sites
  • Indian Institute of Technology, Kharagpur-IIT

    Kharagpur, West Bengal, 721302

    Prof Manjunatha Mahadevappa, 9475329788, mmaha2emb@gmail.com

  • Christian Medical College and Hospital

    Ludhiana, Punjab, 141008

    Dr Dimple Dawar, 9872354078, dawardimple682@gmail.com

  • Christian Medical College and Hospital, Vellore

    Vellore, Tamil Nadu, 632004

    Dr Angel Miraclin, 9488043281, angel_miraclin@yahoo.com

Other trials in India

About this study

Official title: 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.

Read more

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.

Read the 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.

Conditions
Stroke
Being tested
Functional Electrical Stimulation (FES), Standard Rehabilitation
Keywords
Lower limb dysfunction, Gait Impairment, Post Stroke Rehabilitation, Functional Electrical Stimulation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional Electrical Stimulation (FES)Device

    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.

  • Standard RehabilitationOther

    Participants will receive standard outpatient care and home-based rehabilitation without FES, with equivalent remote clinician contact and education.

Study groups in NCT07785700
Study groupRoleWhat they receive
Home-Based FESExperimentalParticipants will receive home-based FES for lower-limb rehabilitation for 12 weeks.
Receives: Device: Functional Electrical Stimulation (FES)
Standard RehabilitationActive comparatorParticipants will receive standard outpatient care and home-based rehabilitation without FES.
Receives: Other: Standard Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline 12 weeks

Secondary outcomes (4)
  1. 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.

    Measured: Baseline to 12 weeks.

  2. 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.

    Measured: Baseline to 12 weeks.

  3. 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.

    Measured: Baseline to 12 weeks.

  4. 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.

    Measured: Baseline to 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion30 Aug 2029 (estimated)
  4. Study completion30 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in a 1:1 ratio to either the home-based Functional Electrical Stimulation (FES) intervention group or the standard rehabilitation control group and will remain in their assigned group throughout the 12-week study period.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07785700
Sponsor's protocol ID
FES
Acronym
FES
Status last verified
Aug 2026
First submitted
21 Aug 2026
Last updated
23 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Popovic MR, Curt A, Keller T, Dietz V. Functional electrical stimulation for grasping and walking: indications and limitations. Spinal Cord. 2001 Aug;39(8):403-12. doi: 10.1038/sj.sc.3101191.

    PubMed 11512070
  • Covarrubias-Escudero F, Balbontin-Miranda F, Urzua-Soler B, Ciuffardi R, Munoz M, Hernandez V, Appelgren-Gonzalez JP. Home-based functional electrical stimulation protocol for people with chronic stroke. Efficacy and usability of a single-center cohort. Artif Organs. 2025 Jul;49(7):1141-1152. doi: 10.1111/aor.14922. Epub 2024 Dec 12.

    PubMed 39665491
  • Shendkar C, Lenka PK, Biswas A, Kumar R, Mahadevappa M. Design and development of a low-cost biphasic charge-balanced functional electric stimulator and its clinical validation. Healthc Technol Lett. 2015 Oct 21;2(5):129-34. doi: 10.1049/htl.2015.0001. eCollection 2015 Oct.

    PubMed 26609419
  • Fang Y, Li J, Liu S, Wang Y, Li J, Yang D, Wang Q. Optimization of electrical stimulation for the treatment of lower limb dysfunction after stroke: A systematic review and Bayesian network meta-analysis of randomized controlled trials. PLoS One. 2023 May 11;18(5):e0285523. doi: 10.1371/journal.pone.0285523. eCollection 2023.

    PubMed 37167257

Questions about this trial

What is this clinical trial studying?

A study testing Functional Electrical Stimulation (FES) and Standard Rehabilitation in people with Stroke, run by Christian Medical College and Hospital, Ludhiana, India at 3 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr. Jeyaraj D Pandian, MD DM (+91 9915784750, jeyarajpandian@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-minute walk test (6MWT) (time frame: Baseline 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07785700, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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