Recruiting

FES Training

Sponsor:

University of Illinois at Chicago

Code:

NCT05849532

Conditions

Chronic Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Functional Electrical Stimulation

Study Details

Brief 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

Study ID

NCT05849532

Start date

Dec 10, 2022

Status verified date

Jul, 2026

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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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Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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) ]
  • Change in Functional balance from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in the Timed up and go test from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in the Four square step test from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in the 30-second chair stand test from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in functional reaching from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in volitional balance via Sensory organization testing from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in isometric muscle strength from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in muscle spasticity from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in the Chedoke McMaster impairment from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in the Fugl-Meyer lower extremity scale from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in the Modified Rankin scale from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in peripheral sensation from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in physical activity from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in balance confidence from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in community participation from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in overall health status from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in overground gait speed from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in global cognition from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in general cognition from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in laboratory induced falls from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in center of mass stability from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in limb support from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in fatigue from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in falls efficacy from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in maximum loading threshold from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]
  • Change in maximum stepping threshold from baseline to mid and post-training [ Time Frame: Baseline (Week 1), mid-training (Week 7) and immediate post-training (Week 12) ]

Central Contacts and Locations

Central contacts

Rudri Purohit, MS

312-413-9772rpuroh2@uic.edu

Jessica Pitts, MS

312-355-3642jpitts5@uic.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612-4225

Contacts

Tanvi Bhatt, PhD

312-355-4443tbhatt6@uic.edu

Rudri Purohit, MS

312-413-9772rpuroh2@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • Chronic stroke
  • Functional electrical stimulation
  • Home-training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-07-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.