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The REACTplusNMES Trial: A Double-blinded RCT

RecruitingNAAges 18 Years - 90 YearsAllUniversity of Illinois at Chicago
NCT06127602 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 compare the effectiveness of 6-weeks of reactive balance training (REACT) with and without neuromuscular electrical stimulation (NMES) to paretic lower limb muscles on biomechanical, clinical, neuromuscular and neuroplastic outcomes of reactive balance control. This project is a Phase-I study and incorporates a double-blinded, randomized controlled trial design. Methods: Forty-six individuals with chronic stroke will be recruited and screened for determining their eligibility for the study. Once enrolled, they will be randomized into either of the two groups: intervention group (23 participants) and control group (23 participants). Both groups will undergo series of pre-training assessments which includes a postural disturbance in the form of a slip- or trip-like perturbations and walking tests in laboratory environment. After the pre-training assessment, ind

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age group: 18-90 years. * Presence of hemiparesis. * Onset of stroke (\> 6 months). * Ability to walk at least for 2 minutes on the treadmill with or without ankle foot orthosis. * Can understand and communicate in English. * Cognitively and behaviorally capable of complying with the regimen (Mini-Mental State Examination \> 25/30). * No history or recent use (i.e., past 6 weeks) of any Neuromuscular electrical stimulation device to leg muscles during walking (e.g., Bioness, Walkaide). 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. * Body weight of more than 250 lbs. * Spasticity (Ashworth scale \> 2). * Loss of protective sensations on the paretic leg (indicated by inability to perceive the 5.07/10 g on Semmes-Weinstein Monofilament) or inability to feel the NMES. * Severe osteoporosis (indicated by T score \< -2) * Cognitive impairment (indicated by Mini-Mental State Exam score\<25) * Global Aphasia (indicated by \<71% on the Mississippi Aphasia Screening Test). * Subjects with Chedoke McMaster Leg Assessment Scale score (\> 4).
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What it tests

  • Reactive balance training with Neuromuscular Electrical Stimulation
  • Reactive balance training without Neuromuscular Electrical Stimulation
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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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