Actively Recruiting
NEUROBALANCE Training to Improve Postural Control in Individuals With Traumatic Brain Injury
Led by Kessler Foundation · Updated on 2025-08-06
45
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
K
Kessler Foundation
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NEUROBALANCE Training to Improve Postural Control in Individuals With Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18-75 years
- Diagnosed with a non-penetrating traumatic brain injury at least six months before screening
- Complaints of impaired balance and poor postural control with a Berg Balance Scale score of 50 or less
- Ability to stand upright with or without support for at least 20 seconds
- Ability to walk with or without a walking aid for at least ten meters
- No plans to change medication within the next four months
- Sufficient cognitive ability to understand instructions and follow study procedures as determined by a capacity to consent assessment
You will not qualify if you...
- Currently participating in regular physical therapy or research studies focused on balance
- History of stroke or penetrating traumatic brain injury
- Peripheral nerve injury, neuromuscular conditions, orthopedic issues of lower limbs before TBI, or persistent pain or difficulty maintaining blood pressure while upright
- Scalp or skin conditions near the brain stimulation site (e.g., psoriasis, eczema)
- Severe visual impairment or hearing problems that affect study compliance
- Other neurological injuries or psychiatric conditions such as severe anxiety or schizophrenia
- Pregnant or planning to become pregnant during the study
- Diagnosed with alcohol or substance abuse within the last three years
- Contraindications to transcranial magnetic stimulation, including metallic implants in the head or history of seizures or medication-resistant epilepsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kessler Foundation
West Orange, New Jersey, United States, 07052
Actively Recruiting
Research Team
V
Vikram Shenoy Handiru, Ph.D.
CONTACT
K
Kathleen Goworek, B.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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