The REACTplusNMES Trial: A Double-blinded RCT

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Stroke, Ischemic, Stroke Hemorrhagic, Stroke, Cerebrovascular

In brief

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.

Key facts

Study ID: NCT06127602
Run by: University of Illinois at Chicago
People needed: 46
Starts: 2024-03-01
Expected to finish: 2027-05-31
Last updated by the study team: 2026-07-07

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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 it is running

University of Illinois at Chicago — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.