Actively Recruiting
The REACTplusNMES Trial: A Double-blinded RCT
Led by University of Illinois at Chicago · Updated on 2025-08-06
46
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The REACTplusNMES Trial: A Double-blinded RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 90 years
- Presence of hemiparesis
- Stroke occurred more than 6 months ago
- Ability to walk at least 2 minutes on a treadmill with or without ankle foot orthosis
- Ability to understand and communicate in English
- Cognitive and behavioral ability to follow the study regimen (Mini-Mental State Examination score above 25/30)
- No use of neuromuscular electrical stimulation devices on leg muscles during walking in the past 6 weeks
You will not qualify if you...
- Heart rate greater than 85% of age-predicted maximum during rest
- Resting systolic blood pressure above 165 mmHg or diastolic blood pressure above 110 mmHg
- Oxygen saturation below 95% at rest
- Body weight over 250 pounds
- Spasticity score greater than 2 on Ashworth scale
- Loss of protective sensation or inability to feel NMES on the affected leg
- Severe osteoporosis (T score below -2)
- Cognitive impairment (Mini-Mental State Exam score below 25)
- Global aphasia (Mississippi Aphasia Screening Test score below 71%)
- Chedoke McMaster Leg Assessment Scale score above 4
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
R
Rudri Purohit, MS
CONTACT
S
Swaranka Deshmukh, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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