Comparing reactive balance training with and without electrical stimulation for stroke recovery
NeuroMuscular Electrical Stimulation to Facilitate Perturbation-based REACtive Balance Training for Fall Risk Reduction Post-stroke: The REACTplusNMES Trial
This study is testing whether adding electrical stimulation to balance training can help people who have had a stroke improve their balance better than training without it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Illinois at Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06127602 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a 6-week reactive balance training program, both with and without the addition of neuromuscular electrical stimulation (NMES) on individuals with chronic stroke. Participants will be randomly assigned to either the intervention group receiving NMES or the control group without it. The study will assess various outcomes related to balance control, including biomechanical, clinical, neuromuscular, and neuroplastic factors. Pre-training assessments will involve simulated postural disturbances to gauge baseline balance capabilities before the training sessions commence.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-90 with chronic hemiparesis resulting from a stroke that occurred more than six months prior.
Not a fit: Patients with severe spasticity, significant cardiovascular issues, or those who cannot comply with the training regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance balance control and reduce fall risk in individuals recovering from stroke.
How similar studies have performed: Previous studies have shown positive outcomes with perturbation-based training in stroke rehabilitation, but this specific combination of reactive balance training and NMES is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Chicago, Illinois
- University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Tanvi Bhatt — University of Illinois at Chicago
- Study coordinator: Rudri Purohit, MS
- Email: rpuroh2@uic.edu
- Phone: 312-413-9772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.