Home-based FES Training in People With Chronic Stroke

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT05849532
Status
Recruiting
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Conditions

  • Chronic Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Functional Electrical Stimulation — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Dec 10, 2022
Status verified
Sep 2025
Primary completion
Jan 30, 2026
Completion
Mar 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Home-training with functional electrical stimulation
    This study employs a single group pre-post design to determine the feasibility, safety and efficacy of a 12-week of home-based combined FES and task-specific training program. Also, this study will test the effect of the same intervention on gait, mobility and balance in adults with chronic stroke.

Primary Outcome Measure

Change in Dynamic balance from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois at ChicagoChicagoIllinois60612-4225
Tanvi Bhatt, PhD
[email protected]
312-355-4443
Rudri Purohit, MS
[email protected]
312-413-9772

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By research site
University of Illinois at Chicago· Chicago, IL

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