Actively Recruiting
Neuromodulation-Enhanced Use of Robotic Balance 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
17 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
This research aims to evaluate the effectiveness of combining robotic balance training with noninvasive brain stimulation to improve balance in adults with chronic traumatic brain injury (TBI). The study focuses on individuals who have had TBI for over six months and experience ongoing balance difficulties. It addresses the need for new rehabilitation methods that support long-term balance recovery and targets sensorimotor and proprioceptive control to help reduce the impact of balance problems in TBI survivors. Participants will be randomly assigned to one of three groups: robotic balance training with active high-definition transcranial direct current stimulation (HD-tDCS), robotic balance training with sham (placebo) stimulation, or standard-of-care rehabilitation exercises. The robotic training uses a device called Hunova which supports dynamic balance exercises in multiple directions and improves trunk control. The intervention includes 12 sessions spread over four weeks, with brain stimulation applied during training in the two robotic groups. During the study, participants will be assessed at the start, immediately after the four-week training period, and two months later to measure balance improvements and brain activity changes. Researchers will evaluate balance using clinical scales such as the Berg Balance Scale and Functional Gait Assessment, as well as neurophysiological tests like EEG and EMG. Feedback on the stimulation and exercise experience will also be collected. The study's total duration includes assessments and follow-up to understand the lasting effects of the interventions.
CONDITIONS
Brief 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 and 75 years
- Diagnosed with a non-penetrating traumatic brain injury at least six months prior to 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 during the next four months
- Sufficient cognitive ability to understand and follow study instructions as assessed by a consent capacity tool
You will not qualify if you...
- Currently participating in any regular physical therapy or balance-focused research studies
- Having had a stroke or a penetrating traumatic brain injury
- History of peripheral nerve injury, neuromuscular conditions, orthopedic problems of lower limbs before TBI, or persistent pain or blood pressure issues while upright
- Scalp or skin conditions near the stimulation site such as psoriasis or eczema
- Severe visual or hearing impairments that may affect study participation
- Other neurological injuries or psychiatric conditions like severe anxiety or schizophrenia
- Pregnancy or planning to become pregnant during the study
- Alcohol or substance abuse diagnosis within the last three years
- Contraindications to transcranial magnetic stimulation, including metallic head implants or history of seizures or medication-resistant epilepsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive 12 sessions of balance and postural control training over 4 weeks. This includes training on a robotic balance platform with or without high-definition transcranial direct current stimulation, or standard-of-care physical therapy exercises.
3 visits per week for 4 weeks (total 12 sessions)
Duration - 2 months
Participants undergo assessments to evaluate the lasting effects of the training on balance and neurophysiological function.
1 visit (in-person)
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.
K
Kathleen Goworek, B.S.
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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