Home-Based Functional Electrical Stimulation for Lower Limb Rehabilitation in Stroke Patients.
FES
Feasibility and Effectiveness of Home-Based Functional Electrical Stimulation (FES) for Lower Limb Rehabilitation in Post-Stroke Individuals
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Sep 2026
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2026
CompletedFirst Posted
Study publicly available on registry
August 25, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2029
Study Completion
Last participant's last visit for all outcomes
August 30, 2029
August 27, 2026
August 1, 2026
3 years
August 21, 2026
August 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Outcome Measure
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 Outcomes (1)
Secondary Outcome
Baseline to 12 weeks.
Study Arms (2)
Home-Based FES
EXPERIMENTALParticipants will receive home-based FES for lower-limb rehabilitation for 12 weeks.
Standard Rehabilitation
ACTIVE COMPARATORParticipants will receive standard outpatient care and home-based rehabilitation without FES.
Interventions
Participants will receive standard outpatient care and home-based rehabilitation without FES, with equivalent remote clinician contact and education.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Christian Medical College and Hospital
Ludhiana, Punjab, 141008, India
Related Publications (4)
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.
PMID: 11512070RESULTCovarrubias-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.
PMID: 39665491RESULTShendkar 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.
PMID: 26609419RESULTFang 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.
PMID: 37167257RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Jeyaraj D Pandian, MD DM
Christian Medical College and Hospital, Ludhiana, India
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors will be blinded to participants' treatment allocation when conducting the study outcome assessments. Participants and care providers will not be blinded because the intervention involves home-based Functional Electrical Stimulation (FES), which is apparent to the participant and treating clinician.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2026
First Posted
August 25, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
August 30, 2029
Study Completion (Estimated)
August 30, 2029
Last Updated
August 27, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
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.