NCT06127602Recruiting
The REACTplusNMES Trial: A Double-blinded RCT
NeuroMuscular Electrical Stimulation to Facilitate Perturbation-based REACtive Balance Training for Fall Risk Reduction Post-stroke: The REACTplusNMES Trial
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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, individuals will undergo 6-weeks of training (2 hour per session, 2 sessions per week). The intervention group will receive NMES with the REACT training and the control group will receive ShamNMES. NMES will be applied to the different muscle groups of the paretic lower limb using an advanced software which is able to synchronize muscle activation with the time of perturbation onset and according to the phases of gait. After training, both groups will again be tested on all the assessments performed pre training. This study will help us understand the immediate therapeutic and mechanistic effects of REACT+NMES and inform stroke rehabilitation research and clinical practice. Our study will provide foundational evidence for future use of NMES to implement clinically applicable neuromodulation adjuvants to reactive balance training, which could be leveraged for designing more effective future interventions for fall-risk reduction.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 25 Oct 2023
- Start date
- Mar 2024
- Primary completion date
- Mar 2027
- Lead sponsor
- University of Illinois Chicago
- Diseases
- Stroke
- NCT number
- NCT06127602
What you commit to
- Study type: Interventional
- Planned participants: 46
- From Mar 2024 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cognitive impairment (indicated by Mini-Mental State Exam score\<25)
Age
- 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.
Other
- 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)
- Global Aphasia (indicated by \<71% on the Mississippi Aphasia Screening Test).
- Subjects with Chedoke McMaster Leg Assessment Scale score (\> 4).
Who the study is looking for
- 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).
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois at Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.