NEUROBALANCE Training to Improve Postural Control in Individuals With Traumatic Brain Injury

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.

Conditions

• Traumatic Brain Injury
• TBI
• Diffuse Axonal Brain Injury
• Brain Injuries, Traumatic

Interventions

DEVICE

Combined (Robotic balance training and high-definition transcranial direct current stimulation)

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.

OTHER

Standard of Care Balance Training

Participants in this group will receive a standard-of-care balance training administered by the Physical therapist.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• Kessler Foundation

  lead OTHER

Principal Investigators

• Vikram Shenoy Handiru, Ph.D. · Kessler Foundation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-01

Primary Completion

2027-08-31

Completion

2027-12-31

FDA Device

Yes

Countries

• United States

Study Locations