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Home-based FES Training in People With Chronic Stroke

RecruitingNAAges 18 Years - 90 YearsAllUniversity of Illinois at Chicago
NCT05849532 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, pa

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📋 Eligibility rules (as published)
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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What it tests

  • Functional Electrical Stimulation
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Where

1 site
University of Illinois at Chicago
Chicago, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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