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Home-based FES Training in People With Chronic Stroke

Sponsored by University of Illinois at Chicago

About this study

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.

BACKGROUND/SCIENTIFIC RATIONALE: Functional impairment after a stroke often includes slowed gait velocity and increased fall risk attributed to foot drop (the inability to dorsiflex the ankle during the swing phase of gait) and lower limb muscle weakness. Damage in the motor cortex or corticospinal tract often results in significant, persistent distal muscle weakness including the sensorimotor control of the ankle joint, typically because of a combination of weakness of the agonist ankle dorsiflexor muscles and spasticity of the antagonist plantarflexor muscle. This results in slower and abnormal gait which leads to gait compensation strategies such as hip hitching, excess circumduction during gait, reduced foot clearance, and high energy expenditure, all of which are factors which could i…

Where this study is enrolling

Who can participate

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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Trial data sourced from ClinicalTrials.gov.