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NCT06127602 · ClinicalTrials.gov registry record · NA
The REACTplusNMES Trial: A Double-blinded RCT
A NA study of Stroke, Ischemic and Stroke Hemorrhagic, sponsored by University of Illinois at Chicago.
- Recruiting
- Registry status
- NA
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT06127602: Recruiting NA study of Stroke, Ischemic and Stroke Hemorrhagic, sponsored by University of Illinois at Chicago.
NCT06127602 is a NA study of Stroke, Ischemic and Stroke Hemorrhagic that is actively recruiting participants, run by University of Illinois at Chicago. The registered enrollment target is 46 participants, below the 288-participant average among 33 other Stroke, Ischemic trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06127602, a NA study of Stroke, Ischemic and Stroke Hemorrhagic, is actively recruiting participants, sponsored by University of Illinois at Chicago.
- RECRUITING
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
A fall will be detected when the force exerted through the safety-harness load cell exceeds 30% of a person's body weight and verified with video analysis. Otherwise, the trial will be a balance recovery. Higher percentages indicate more falls.
Conditions Studied
Interventions
- BEHAVIORAL Reactive balance training with Neuromuscular Electrical Stimulation
- BEHAVIORAL Reactive balance training without Neuromuscular Electrical Stimulation
Study Locations (1)
Illinois
- University of Illinois at Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2026-05-31 |
| Phase | NA |
What NCT06127602 shows while recruiting
NCT06127602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 288-participant average among 33 other Stroke, Ischemic trials with a reported enrollment target (84% lower).
The record links to 3 conditions, with Stroke, Ischemic appearing as the primary indexed condition, and to 2 interventions - of which Reactive balance training with Neuromuscular Electrical Stimulation is the first listed.
NCT06127602 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06127602 about?
NCT06127602 is a clinical study titled "The REACTplusNMES Trial: A Double-blinded RCT". 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 proje...
What is the current status of trial NCT06127602?
This trial is currently recruiting. It is a NA study. The enrollment target is 46 participants. The study started on 2024-03-01. Estimated completion is 2026-05-31.
What conditions does trial NCT06127602 study?
This clinical trial studies the following conditions: Stroke, Ischemic, Stroke Hemorrhagic, Stroke, Cerebrovascular.
What interventions are being tested in trial NCT06127602?
The interventions under investigation include: Reactive balance training with Neuromuscular Electrical Stimulation (BEHAVIORAL), Reactive balance training without Neuromuscular Electrical Stimulation (BEHAVIORAL).
Who is sponsoring clinical trial NCT06127602?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06127602 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06127602's enrollment target sits among peer trials
46 22nd of 33 higher than 12 of 33 other Stroke, Ischemic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke, Ischemic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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