Home-based functional electrical stimulation training for chronic stroke patients

Feasibility and Efficacy of Home-Based Functional Electrical Stimulation and Task-Specific Training in Adults With Chronic Stroke

This study is testing if a home-based electrical stimulation program can help people who have had a stroke improve their walking and balance over 12 weeks.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: University of Illinois at Chicago (other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT05849532 on ClinicalTrials.gov

What this trial studies

This project investigates the feasibility, safety, and effects of home-based functional electrical stimulation (FES) combined with task-specific training on gait, balance, and mobility in adults with chronic stroke. Participants will first undergo assessments in a laboratory to determine eligibility, followed by a 12-week program that includes initial training sessions and home-based training with an FES device. The study aims to improve walking and reduce fall risk by addressing muscle weakness and impaired motor control associated with chronic stroke.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-90 with unilateral hemiparesis who can walk independently for at least 300 feet.

Not a fit: Patients with severe cognitive impairment, other neurological conditions, or uncontrolled medical issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance mobility and reduce fall risk for patients with chronic stroke.

How similar studies have performed: Previous studies have shown promise with functional electrical stimulation in rehabilitation, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age group: 18-90 years.
2. Presence of unilateral hemiparesis.
3. Onset of stroke (\> 6 months).
4. Ability to walk independently with or without an assistive device for at least 300 ft.
5. Can understand and communicate in English and can verbalize discomfort or pain in English
6. Use of smartphone on a daily basis
7. Availability of internet/Wi-Fi at home

Exclusion Criteria:

1. Body weight more than 250 lbs.
2. Heel bone density measurement using an ultrasound device. Individuals classified as osteoporotic (i.e., with a T-score \< -2) will be excluded.
3. Cognitive impairment (Montreal Cognitive assessment score \<26/30)
4. Verbal Aphasia (i.e \<71% score on Mississippi Aphasia Screening)
5. Severe depression (\> 15 points on geriatric depression scale)
6. Any neurological condition other than stroke.
7. Uncontrolled and/or untreated hypertension/hypotension, uncontrolled and/or untreated diabetes and any musculoskeletal, neuromuscular or systemic diagnosis .
8. Recent major surgery (\< 6 months) or hospitalization (\< 3 months).
9. Deep venous thrombosis.
10. Past or current history of any type of active cancer
11. Peripheral nerve injury or neuropathy in the affected limb with motor disability.
12. Uncontrolled high blood pressure/angina.
13. Skin condition not tolerant with FES therapy.
14. Past or current history of uncontrolled/controlled epilepsy or any other types of seizure disorders
15. Botox treatment within the last 5 months.
16. Pacemaker users.

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Where this trial is running

Chicago, Illinois

• University of Illinois at Chicago — Chicago, Illinois, United States (RECRUITING)

Study contacts

• Principal investigator: Tanvi Bhatt, PhD — University of Illinois at Chicago
• Study coordinator: Rudri Purohit, MS

Conditions: Chronic Stroke, Chronic stroke, Functional electrical stimulation, Home-training