RECRUITING

Home-based FES Training in People With Chronic Stroke

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Conditions

Chronic StrokeFunctional electrical stimulationHome-training

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-12-10
Study Completion:2025-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05849532

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age group: 18-90 years.
  2. 2. Presence of unilateral hemiparesis.
  3. 3. Onset of stroke (\> 6 months).
  4. 4. Ability to walk independently with or without an assistive device for at least 300 ft.
  5. 5. Can understand and communicate in English and can verbalize discomfort or pain in English
  6. 6. Use of smartphone on a daily basis
  7. 7. Availability of internet/Wi-Fi at home
  1. 1. Body weight more than 250 lbs.
  2. 2. Heel bone density measurement using an ultrasound device. Individuals classified as osteoporotic (i.e., with a T-score \< -2) will be excluded.
  3. 3. Cognitive impairment (Montreal Cognitive assessment score \<26/30)
  4. 4. Verbal Aphasia (i.e \<71% score on Mississippi Aphasia Screening)
  5. 5. Severe depression (\> 15 points on geriatric depression scale)
  6. 6. Any neurological condition other than stroke.
  7. 7. Uncontrolled and/or untreated hypertension/hypotension, uncontrolled and/or untreated diabetes and any musculoskeletal, neuromuscular or systemic diagnosis .
  8. 8. Recent major surgery (\< 6 months) or hospitalization (\< 3 months).
  9. 9. Deep venous thrombosis.
  10. 10. Past or current history of any type of active cancer
  11. 11. Peripheral nerve injury or neuropathy in the affected limb with motor disability.
  12. 12. Uncontrolled high blood pressure/angina.
  13. 13. Skin condition not tolerant with FES therapy.
  14. 14. Past or current history of uncontrolled/controlled epilepsy or any other types of seizure disorders
  15. 15. Botox treatment within the last 5 months.
  16. 16. Pacemaker users.

Contacts and Locations

Study Contact

Rudri Purohit, MS
CONTACT
312-413-9772
rpuroh2@uic.edu
Jessica Pitts, MS
CONTACT
312-355-3642
jpitts5@uic.edu

Principal Investigator

Tanvi Bhatt, PhD
PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago

Study Locations (Sites)

University of Illinois at Chicago
Chicago, Illinois, 60612-4225
United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

  • Tanvi Bhatt, PhD, PRINCIPAL_INVESTIGATOR, University of Illinois at Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-10
Study Completion Date2025-01-30

Study Record Updates

Study Start Date2022-12-10
Study Completion Date2025-01-30

Terms related to this study

Keywords Provided by Researchers

  • Chronic stroke
  • Functional electrical stimulation
  • Home-training

Additional Relevant MeSH Terms

  • Chronic Stroke