NCT05849532 · University of Illinois at Chicago
Home-based FES Training in People With Chronic Stroke
(HomeFES)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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.
- Cognitive impairment (Montreal Cognitive assessment score \<26/30)
- Verbal Aphasia (i.e \<71% score on Mississippi Aphasia Screening)
- Severe depression (\> 15 points on geriatric depression scale)
- Any neurological condition other than stroke.
- Uncontrolled and/or untreated hypertension/hypotension, uncontrolled and/or untreated diabetes and any musculoskeletal, neuromuscular or systemic diagnosis .
- Recent major surgery (\< 6 months) or hospitalization (\< 3 months).
- Deep venous thrombosis.
- Past or current history of any type of active cancer
- Peripheral nerve injury or neuropathy in the affected limb with motor disability.
- 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
- Botox treatment within the last 5 months.
- Pacemaker users. \-
Where
- Chicago, Illinois
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations