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NCT06584591 · ClinicalTrials.gov registry record · NA
NEUROBALANCE Training to Improve Postural Control in Individuals With Traumatic Brain Injury
A NA study of Traumatic Brain Injury and Brain Injuries, Traumatic, sponsored by Kessler Foundation.
- Recruiting
- Registry status
- NA
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT06584591: Recruiting NA study of Traumatic Brain Injury and Brain Injuries, Traumatic, sponsored by Kessler Foundation.
NCT06584591 is a NA study of Traumatic Brain Injury and Brain Injuries, Traumatic that is actively recruiting participants, run by Kessler Foundation. The registered enrollment target is 45 participants, below the 277-participant average among 171 other Traumatic Brain Injury 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
NCT06584591, a NA study of Traumatic Brain Injury and Brain Injuries, Traumatic, is actively recruiting participants, sponsored by Kessler Foundation.
- RECRUITING
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
Our proposed study, \"NEUROBALANCE,\" aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive brain stimulation in improving balance functions in individuals with chronic traumatic brain injury (TBI). The study will recruit 45 participants who have had a TBI for over six months and experience persistent balance deficits. Participants will be randomized into three groups: (1) robotic balance training with active brain stimulation, (2) robotic balance training with sham brain stimulation, and (3) standard-of-care rehabilitation. The study will involve 12 training sessions over four weeks, with assessments conducted at baseline, post-training, and two months post-training to evaluate balance recovery and retention. The primary focus is understanding how this intervention affects brain and muscle activity during balance tasks and how these changes translate into functional improvements in clinical outcome measures of balance function. Additionally, participant feedback on brain stimulation and exercise engagement will be collected to inform future studies. This research is particularly relevant to military service members, as TBI and balance impairments are common among this population. The findings may guide the development of personalized training protocols and contribute to broader rehabilitation strategies.
Primary Outcome
A widely used outcome measure of static standing balance function (Newstead et al., 2005), categorized under the 'Activity' subsection of ICF domain. BBS scores range from 0 to 56 (the higher, the better). The change in BBS scores from baseline to 4 weeks post-training will be the primary endpoint.
Conditions Studied
Interventions
- DEVICE Combined (Robotic balance training and high-definition transcranial direct current stimulation)
- OTHER Standard of Care Balance Training
Study Locations (1)
New Jersey
- Kessler Foundation - West Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2025-08-01 |
| Est. Completion | 2027-12 |
| Phase | NA |
What NCT06584591 shows while recruiting
NCT06584591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (84% lower).
The record links to 4 conditions, with Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which Combined (Robotic balance training and high-definition transcranial direct current stimulation) is the first listed.
NCT06584591 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT06584591 about?
NCT06584591 is a clinical study titled "NEUROBALANCE Training to Improve Postural Control in Individuals With Traumatic Brain Injury". Our proposed study, \"NEUROBALANCE,\" aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive brain stimulation in improving balance functions in individuals with chronic traumatic brain injury (TBI). The study will recruit 45 particip...
What is the current status of trial NCT06584591?
This trial is currently recruiting. It is a NA study. The enrollment target is 45 participants. The study started on 2025-08-01. Estimated completion is 2027-12.
What conditions does trial NCT06584591 study?
This clinical trial studies the following conditions: Traumatic Brain Injury, Brain Injuries, Traumatic, TBI, Diffuse Axonal Brain Injury.
What interventions are being tested in trial NCT06584591?
The interventions under investigation include: Combined (Robotic balance training and high-definition transcranial direct current stimulation) (DEVICE), Standard of Care Balance Training (OTHER).
Who is sponsoring clinical trial NCT06584591?
This trial is sponsored by Kessler Foundation, which has 104 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06584591 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06584591's enrollment target sits among peer trials
45 125th of 171 higher than 45 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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