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Home-based FES Training in People With Chronic Stroke

NCT05849532 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-19

No results posted yet for this study

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.

Conditions

  • Chronic Stroke

Interventions

DEVICE

Functional Electrical Stimulation

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.

Sponsors & Collaborators

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Tanvi Bhatt, PhD · University of Illinois at Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-10
Primary Completion
2026-01-30
Completion
2026-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05849532 on ClinicalTrials.gov