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
University of Illinois at Chicago
30 participants
Dec 10, 2022
INTERVENTIONAL
Summary
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.
Eligibility
Inclusion Criteria7
- 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 Criteria17
- 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.
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Interventions
12-weeks of training sessions that include initial screening and clinical assessment (Week 1-2), onsite training sessions (Week 3-4), home training sessions (Week 4-8). There will also be pre (Week 1), mid (Week 7) and post-training (Week 12) assessment. Each session will consist of a 10-minute warm-up session with 5-6 stretching exercises. Warm-up will be followed by a 30 minute training session comprising of mobility, balance and walking exercises with FES. This will be followed by a cool down session for 10-minutes comprising of 5-6 muscle stretches. The participant will first watch video of the each exercise on the android tablet and then perform the exercises.
Locations(1)
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NCT05849532