NCT05849532Recruiting
Home-based FES Training in People With Chronic Stroke
Feasibility and Efficacy of Home-Based Functional Electrical Stimulation and Task-Specific Training in Adults With Chronic Stroke
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
This project will examine the feasibility, safety and effect of home-based functional electrical stimulation (FES) applied to different lower limb muscles in combination with task-specific training on gait, balance and mobility in adults with chronic stroke. 30 individuals with chronic stroke will first undergo initial screening and baseline walking, mobility, balance and strength assessments in the laboratory. After determining their eligibility for the study, they will undergo 12-weeks of home-based FES and task-specific training. Following the initial screening (week 1) and pre-intervention assessment (week 2), participants will be trained in the lab for 6 sessions (week 3-4) for a FES home program and then given a FES home kit (FES device and an android tablet). Participants will then undergo home-training for 2 weeks (week 5-6) followed by mid-training assessment (week 7). Again, participants will undergo 4-weeks of home training (week 8-11) and final assessment at the end of training (week 12). This project has the following specific aims: Aim 1: To investigate the feasibility, safety and efficacy of 12-weeks of home-based FES and task-specific training in adults with chronic stroke. Aim 2: To examine the effect of 12-weeks of home-based FES and task-specific training on mobility, gait and balance (anticipatory and reactive balance) in adults with chronic stroke.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 16 Jan 2023
- Start date
- 10 Dec 2022
- Primary completion date
- 30 Jan 2027
- Lead sponsor
- University of Illinois Chicago
- Diseases
- Stroke
- NCT number
- NCT05849532
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 10 Dec 2022 to the primary completion date, 30 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent major surgery (\< 6 months) or hospitalization (\< 3 months).
Other illness
- Cognitive impairment (Montreal Cognitive assessment score \<26/30)
- Any neurological condition other than stroke.
- Uncontrolled and/or untreated hypertension/hypotension, uncontrolled and/or untreated diabetes and any musculoskeletal, neuromuscular or systemic diagnosis .
- Deep venous thrombosis.
- Past or current history of any type of active cancer
- Uncontrolled high blood pressure/angina.
- Skin condition not tolerant with FES therapy.
- Past or current history of uncontrolled/controlled epilepsy or any other types of seizure disorders
Other
- Body weight more than 250 lbs.
- Heel bone density measurement using an ultrasound device. Individuals classified as osteoporotic (i.e., with a T-score \< -2) will be excluded.
- Verbal Aphasia (i.e \<71% score on Mississippi Aphasia Screening)
- Severe depression (\> 15 points on geriatric depression scale)
- Peripheral nerve injury or neuropathy in the affected limb with motor disability.
- Botox treatment within the last 5 months.
- Pacemaker users.
- \-
Who the study is looking for
- Age group: 18-90 years.
- Presence of unilateral hemiparesis.
- Onset of stroke (\> 6 months).
- Ability to walk independently with or without an assistive device for at least 300 ft.
- Can understand and communicate in English and can verbalize discomfort or pain in English
- Use of smartphone on a daily basis
- Availability of internet/Wi-Fi at home
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois at Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.