[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653204":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":29,"studyPopulation":18,"armGroups":30,"interventions":43,"overallOfficials":52,"centralContacts":56,"locations":65,"responsibleParty":83,"collaborators":85,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":18,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":114,"whyStopped":18,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Christian Medical College and Hospital, Ludhiana, India","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14],{"measure":15,"description":16,"timeFrame":17},"Secondary Outcome","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.",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"RANDOMIZED","PARALLEL","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.","TREATMENT",{"masking":25,"maskingDescription":26,"whoMasked":27},"SINGLE","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.",[28],"OUTCOMES_ASSESSOR","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.\n\nThis 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.\n\nCondition 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.\n\nStudy 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.\n\nThe 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\u002Fbench validation, and preparation of units for clinical evaluation. The second phase involves implementation of the feasibility randomized controlled trial at participating clinical sites.\n\nBefore 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.\n\nThe 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.\n\nThe 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.",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"Home-Based FES","EXPERIMENTAL","Participants will receive home-based FES for lower-limb rehabilitation for 12 weeks.",[36],"Device: Functional Electrical Stimulation (FES)",{"label":38,"type":39,"description":40,"interventionNames":41},"Standard Rehabilitation","ACTIVE_COMPARATOR","Participants will receive standard outpatient care and home-based rehabilitation without FES.",[42],"Other: Standard Rehabilitation",[44,49],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":18},"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.",[32],{"type":6,"name":38,"description":50,"armGroupLabels":51,"otherNames":18},"Participants will receive standard outpatient care and home-based rehabilitation without FES, with equivalent remote clinician contact and education.",[38],[53],{"name":54,"affiliation":5,"role":55},"Dr. Jeyaraj D Pandian, MD DM","PRINCIPAL_INVESTIGATOR",[57,61],{"name":54,"role":58,"phone":59,"phoneExt":18,"email":60},"CONTACT","+91 9915784750","jeyarajpandian@hotmail.com",{"name":62,"role":58,"phone":63,"phoneExt":18,"email":64},"Dr. Dimple Dawar, OT","+91 9872354078; +1 905 9627200","dawardimple682@gmail.com",[66],{"facility":67,"status":18,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Christian Medical College and Hospital","Ludhiana","Punjab","141008","India","IN",{"type":74,"coordinates":75},"Point",[76,77],75.85379,30.91204,{"lat":77,"lon":76},[80],{"name":81,"role":58,"phone":82,"phoneExt":18,"email":64},"Dr Dimple Dawar","9872354078",{"type":84,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[86],{"name":87,"class":88},"Indian Council of Medical Research","OTHER_GOV","100653204","home-based-functional-electrical-stimulation-for-lower-limb-rehabilitation-in-stroke-patients-100653204",false,"NCT07785700","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","FES","Inclusion Criteria:\n\n1. Age ≥ 18 years with ischemic or hemorrhagic stroke (one month to one year post stroke)\n2. 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.\n3. Cognitively able to follow instructions and provide informed consent (e.g., MMSE ≥ 24 or equivalent screening, or judged capable by the investigator).\n4. Access to a compatible smartphone and home internet service and willing\u002Fable to use the tele-rehab app.\n5. Skin at electrode application sites intact (no open wounds) and no dermatologic condition that would prevent safe application of the sleeve.\n\nExclusion Criteria:\n\n1. 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.\n2. Active seizure disorder (epilepsy) that is uncontrolled or where stimulation could increase seizure risk, diabetes mellitus.\n3. Pregnancy or breastfeeding.\n4. Known allergy to materials used in the FES sleeve or electrodes.\n5. Severe spasticity in target muscle groups (e.g., Modified Ashworth Scale ≥ 3) that prevents functional stimulation or safe participation.\n6. 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).\n7. Severe cognitive impairment, active psychiatric illness, or communication barriers that preclude safe device use or reliable consent\u002Fassessment.\n8. Open wounds, skin infection, severe dermatitis, or other skin conditions at electrode or sleeve contact sites.\n9. Participation in another interventional trial that would conflict with outcomes or safety reporting for this sub study.","ALL","18 Years","99 Years",{"count":101,"type":102},70,"ESTIMATED","INTERVENTIONAL",[105],"NA","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.\n\nAdults 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.\n\nParticipants 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.\n\nParticipants 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.\n\nThe 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.\n\nThe 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.",[108],"Stroke",[110,111,112,113],"Lower limb dysfunction","Gait Impairment","Post Stroke Rehabilitation","Functional Electrical Stimulation","NOT_YET_RECRUITING","2026-08-21",{"date":117,"type":118},"2026-08-25","ACTUAL",{"date":120,"type":102},"2027-01-01",{"date":122,"type":102},"2030-12-31",{"name":5,"class":6},1]