What this study is
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.
What's being tested
- Combined (Robotic balance training and high-definition transcranial direct current stimulation)
Intervention · DEVICE
The robotic platform will train the participants to maintain dynamic balance in the sagittal and the transverse planes (mediolateral and anterior-posterior directions) and engage in core stability and trunk control with seated balance exercises. In addition, high-definition transcranial direct current stimulation (HD-tDCS) will be used as an adjuvant to robotic balance training by priming the corticospinal circuits.
- Standard of Care Balance Training
Intervention · OTHER
Participants in this group will receive a standard-of-care balance training administered by the Physical therapist.
Study details
- Official title
- Neuromodulation-Enhanced Use of RObotic Balance Training to Improve Postural Control in Individuals With Traumatic Brain Injury
- Sponsor
- Kessler Foundation
- Conditions
- Traumatic Brain Injury · TBI · Diffuse Axonal Brain Injury · Brain Injuries, Traumatic
- Enrolling
- 45 people
- Starts
- 2025-08-01
- Est. completion
- 2027-12
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Aged between 18-75 years
- Diagnosed with a non-penetrating TBI at least six months before the screening.
- Have complaints of impaired balance and poor postural control determined by a BBS score of ≤50.
- 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
- Not planning to change medication in the next four months
- Minimum Cognitive Ability to understand the verbal instructions and comply with the study procedures, as determined by the University of California, San Diego, Brief Assessment of Capacity to Consent Instrument (UBACC).
You can't join if
- Currently undergoing any regular physical therapy program or research studies focusing on balance functions.
- Having a stroke or a penetrating TBI.
- Affected by the peripheral nerve injury, neuromuscular conditions, or orthopedic issues of lower limbs before TBI, or have any persistent pain or difficulty maintaining blood pressure while upright.
- Have a scalp or skin condition (e.g., psoriasis or eczema) on the scalp near the stimulation site.
- Severe visual impairment (e.g., spatial neglect) or hearing problems may affect study compliance.
- Any other neurological injury or psychiatric conditions (e.g., severe anxiety or schizophrenia, etc.)
- Not being pregnant or thinking of becoming pregnant during the study period.
- Diagnosed with alcohol or substance abuse in the last three years.
- Contraindications to TMS, including the presence of metallic implants in the head and history of seizures or medication-resistant epilepsy.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openKessler Foundation
West Orange, New Jersey, United States
- Vikram Shenoy Handiru, Ph.D. · Contact
- Kiran Karunakaran, Ph.D. · Sub-investigator
- Karen Nolan, Ph.D. · Sub-investigator
- Easter Selvan Suviseshamuthu, Ph.D. · Sub-investigator
Recruiting
Study team
Sponsor
Kessler Foundation
Study ID R-1261-24
Principal investigator
Vikram Shenoy Handiru, Ph.D.
Kessler Foundation
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.