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Effect of NMES on Balance and Fall Risk in Chronic Stroke

RecruitingNAAges 18 Years - 90 YearsAllUniversity of Illinois at Chicago
NCT04957355 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of this study is to describe the effect of neuromuscular electrical stimulation (NMES) in the form of functional electrical stimulation (FES) applied to different lower limb muscles on reactive balance and gait performance in stroke participants. Methods: Twenty individuals with chronic stroke will be asked to perform an experimental protocol that includes a postural disturbance in the form of a slip- or trip-like perturbation and a standardized walking test in both laboratory and outdoor environments with and without FES applied to different lower limb muscles of the paretic leg. FES will be applied using an advanced software that is able to synchronize muscle activation with the time of perturbation onset and according to the phases of gait. This project design aims to examine whether a specific pattern of lower limb muscle stimulation could improve the kinematic and behavior

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📋 Eligibility rules (as published)
Inclusion Criteria: Age group: 18-90 years. 1. Presence of hemiparesis. 2. Onset of stroke (\> 6 months). 3. Ability to walk independently with or without an assistive device for at least 300 ft. 4. Can understand and communicate in English. 5. Cognitively and behaviorally capable of complying with the regimen (Montreal Cognitive Assessment \> 25/30). Exclusion Criteria: Subjects will not proceed with the test if any of the following occurs at baseline measurement: 1) HR \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during rest, or 3) oxygen saturation (measured by pulse oximeter) \< 95% during rest. 1. Body weight more than 250 lbs. 2. Any neurological condition other than stroke. 3. Any cardiopulmonary, musculoskeletal, or systemic diagnosis. 4. Recent major surgery (\< 6 months) or hospitalization (\< 3 months). 5. Deep venous thrombosis. 6. Antecedent of cancer. 7. Peripheral nerve injury or neuropathy in the affected limb with motor disability. 8. Spasticity (Ashworth scale \> 2). 9. Uncontrolled high blood pressure/angina. 10. Skin condition not tolerant with FES therapy. 11. Uncontrolled seizure disorder. 12. Botox treatment within the last 5 months. 13. History of epilepsy. 14. Pacemaker users. Excluded or Vulnerable Populations Non-English speaking populations will be excluded as the consent procedures and instructions will be in English.
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What it tests

  • Neuromuscular electrical stimulation (NMES) or Functional electrical stimulation (FES)
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Where

1 site
University of Illinois at Chicago
Chicago, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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