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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
University of Illinois at Chicago
RECRUITING
Chicago
Contact Information
Primary
Rudri Purohit, MS
rpuroh2@uic.edu
312-413-9772
Backup
Jessica Pitts, MS
jpitts5@uic.edu
312-355-3642
Time Frame
Start Date: 2022-12-10
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Illinois at Chicago

This content was sourced from clinicaltrials.gov