Complex Balance Tasks for Traumatic Brain Injury

Overseen By Brigette Cox, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Bone therapies, Hormones, Glucocorticoids

Disqualifiers: Neurological injury, PTSD, Arthritis, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how a moderate traumatic brain injury (TBI) from years ago might affect balance and thinking skills as people age. Researchers aim to determine if participants with a TBI perform worse on balance and cognitive tests, even if they believe they have fully recovered. Participants will engage in complex balance tasks, a form of physical therapy for balance, to help identify potential rehabilitation methods for Veterans. Ideal candidates are Veterans aged 50 to 65 who had a moderate TBI at least 10 years ago and currently feel fully recovered from the TBI. As an unphased trial, this study offers Veterans a unique opportunity to contribute to understanding the long-term effects of TBI and potential rehabilitation strategies.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications that affect bone mineral density or involve chronic use of systemic glucocorticoids. If you're taking these, you may need to stop before joining the study.

What prior data suggests that these complex balance tasks are safe for participants?

Research has shown that balance training is generally safe for individuals who have experienced a traumatic brain injury (TBI). Studies on rehabilitation methods for TBI indicate that these exercises can aid attention and memory issues without causing major side effects. Additionally, research comparing virtual reality and regular physical therapy for balance improvement found no significant safety differences. This suggests that balance exercises are usually well-tolerated. Although specific safety details aren't always provided, the widespread use of balance exercises in various therapies without major problems is reassuring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using complex balance tasks for traumatic brain injury (TBI) because these exercises focus on improving the brain's ability to manage balance and coordination. Unlike traditional physical therapy that often targets general motor skills, complex balance tasks specifically challenge the brain to adapt and rewire itself by engaging multiple sensory and motor systems simultaneously. This method has the potential to address the nuanced deficits in balance and coordination seen in TBI patients more effectively. Additionally, it can be adapted for individuals both with and without a history of TBI, making it a versatile approach.

What evidence suggests that complex balance tasks are effective for improving balance in individuals with a history of traumatic brain injury?

Research has shown that exercises to improve balance can help people with traumatic brain injury (TBI) become more stable. Although evidence remains limited, some studies suggest that physical therapy focusing on balance aids recovery. Balance is crucial for everyday activities, and improving it can reduce the risk of falls or further injury. While early results vary, therapies focusing on balance appear promising for enhancing the quality of life for TBI patients. This trial will evaluate the effectiveness of Complex Balance Tasks, aiming to help those with TBI maintain independence as they age. ^{1 4 5 6 7}

Who Is on the Research Team?

David J. Clark, DSc

Principal Investigator

North Florida/South Georgia Veterans Health System, Gainesville, FL

Are You a Good Fit for This Trial?

This trial is for individuals aged 50-65 who had a moderate traumatic brain injury (TBI) at least 15 years ago, consider themselves fully recovered, and can travel to the research site. They must have good balance confidence and cognitive function scores. People with severe health issues like uncontrolled hypertension or diabetes, recent cancer treatment (except certain skin cancers), substance abuse, or other conditions affecting balance or cognition cannot join.

Inclusion Criteria

I had a moderate brain injury from a closed-head impact over 15 years ago.

Affirmative response to considering oneself fully recovered from the TBI

I live at home and can travel to the study location.

Exclusion Criteria

My BMI is over 35, indicating severe obesity.

I have a neurological condition, but it's not a moderate traumatic brain injury.

Current substance abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants with and without TBI history complete balance intervention sessions

1 session (30 minutes)

1 visit (in-person)

Follow-up

Participants are monitored for changes in balance and cognitive function after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Complex Balance Tasks

Trial Overview The study tests how well people who had a TBI in the past perform on complex balance tasks and cognitive tests despite feeling recovered. It aims to understand aging effects after TBI and develop future rehabilitative interventions for maintaining brain health.

How Is the Trial Designed?

Group I: Balance Intervention Experimental Treatment 1 Intervention

Participants with TBI history and without TBI history will both complete the same intervention.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A Perturbation-based Balance Training program with visual cues (PBTvc) was evaluated in a feasibility study involving two participants with chronic Traumatic Brain Injury (TBI), showing promising improvements in balance mechanisms.

After 16 sessions of PBTvc, participants demonstrated enhanced trunk stability and reduced time to regain balance during perturbations, along with better scores on balance assessments, indicating potential for functional recovery in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Anticipatory and Compensatory Postural Responses to Improve Balance in Individuals with TBI. Tendolkar, PA., Ibironke, O., Nolan, KJ., et al.[2023]

This study evaluated computerized posturography testing (CPT) in 21 ambulatory patients with severe traumatic brain injury (TBI) during their rehabilitation, highlighting its effectiveness in detecting and quantifying balance impairments.

Despite some patients achieving high scores on the Functional Independence Measure (FIM) ambulation scale, CPT revealed significant postural instability, suggesting that traditional measures may not fully capture balance issues in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objectively assessing balance deficits after TBI: Role of computerized posturography. Pickett, TC., Radfar-Baublitz, LS., McDonald, SD., et al.[2022]

A 12-week home-based physical therapy program using virtual reality (VR) did not show significant advantages over a traditional home exercise program (HEP) in improving balance for individuals with traumatic brain injury (TBI).

Both the VR and traditional HEP groups demonstrated significant improvements in balance measures over time, indicating that independent home-based interventions can be effective for enhancing balance in chronic TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results From a Randomized Controlled Trial to Address Balance Deficits After Traumatic Brain Injury. Tefertiller, C., Hays, K., Natale, A., et al.[2022]

Individuals with moderate to severe traumatic brain injury (TBI) show significant impairments in balance control, particularly in anticipatory and reactive mechanisms, as indicated by increased spectral power in balance tasks.

Recovery in balance control occurs over time, with improvements in inter-limb coherence and high-frequency balance measures, suggesting that targeted rehabilitation addressing weight-bearing asymmetries could enhance balance and reduce fall risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spectral analysis of centre of pressure identifies altered balance control in individuals with moderate-severe traumatic brain injury. Habib Perez, O., Green, RE., Mochizuki, G.[2021]

A conventional exercise program for patients with mild-to-moderate traumatic brain injury (TBI) significantly improved postural stability and gait after 20 therapy sessions over four weeks, as shown by increases in the Berg Balance Scale and Functional Gait Assessment scores.

Participants also experienced a reduction in ataxia, indicating enhanced coordination in both upper and lower extremities, which suggests that this targeted exercise approach may be effective in rehabilitating TBI-related deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy for correcting postural and coordination deficits in patients with mild-to-moderate traumatic brain injury. Ustinova, KI., Chernikova, LA., Dull, A., et al.[2014]

Individuals with mild traumatic brain injury (TBI) showed greater decomposition in their postural and arm movements compared to healthy controls, indicating difficulties in coordinating these movements during a reaching task.

The study found that the degree of movement decomposition in TBI patients correlated negatively with their postural stability, suggesting that these coordination issues may stem from impaired postural control or compensatory strategies, which should be considered in rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decomposition of postural movements in individuals with mild TBI while reaching to intercept a moving virtual target. Ustinova, KI.[2018]

A study involving 37 adults with moderate-to-severe traumatic brain injury (TBI) evaluated various clinical balance assessments to identify effective tools for detecting balance impairments within 6 months post-injury.

The research highlighted that while some assessments like the Berg Balance Scale (BBS) showed ceiling effects, a combination of the NIH Standing Balance Test (NIH-SBT), Walking While Talking Test (WWTT), and Advanced Functional Gait Assessment (FGA-A) provided a versatile approach to assess balance across different severity levels in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balance impairment in patients with moderate-to-severe traumatic brain injury: Which measures are appropriate for assessment? Joyce, JM., Debert, CT., Chevignard, M., et al.[2022]

The studies aim to characterize balance deficits in individuals with chronic post-concussive syndrome and compare them to healthy controls, focusing on central sensorimotor integration as a key factor in balance issues after mild traumatic brain injury (mTBI).

A randomized controlled trial will assess the efficacy of a 6-week vestibular rehabilitation program, with and without auditory biofeedback, to improve balance and daily activity in patients with mTBI, potentially offering new insights into effective rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment and rehabilitation of central sensory impairments for balance in mTBI using auditory biofeedback: a randomized clinical trial. Fino, PC., Peterka, RJ., Hullar, TE., et al.[2018]

The study evaluated a balance protocol combining static (BESS) and dynamic (modified SEBT) assessments in healthy adults, finding that the modified SEBT showed moderate to strong reliability, while the BESS had limited reliability.

Unipedal stances resulted in greater variability than bipedal stances, suggesting that dynamic assessments may provide more consistent data for evaluating postural control, especially in future studies involving pediatric populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ASSESSING STATIC AND DYNAMIC POSTURAL CONTROL IN A HEALTHY POPULATION. Campolettano, ET., Gellner, RA., Rowson, S.[2022]

A systematic review of eight studies involving 259 individuals with post-traumatic brain injury (TBI) found that physical therapy interventions had limited evidence in improving balance deficits, with no significant differences observed between various types of interventions, including virtual reality and vestibular rehabilitation therapy.

The methodological quality of the studies varied, and the authors concluded that more randomized controlled trials are needed to better understand the effectiveness of physical therapy for balance impairments in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of physical therapy interventions on balance ability in people with traumatic brain injury: A systematic review. Alashram, AR., Annino, G., Raju, M., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3319122/

Effectiveness of physical therapy for improving gait and ... We found limited evidence of the positive effects of balance, gait, or the combination of both interventions, in TBI rehabilitation.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9381921/

Balance impairment in patients with moderate-to-severe ... Balance is integral to daily function and TBI patients with poor balance are at high risk for re-injury. Earlier commencement and greater ...

3. rimed.org rimed.org/rimedicaljournal/2025/08/2025-08-20-tbi-vinacco.pdf

Restoring Function After TBI: A Review of Physical Therapy ... A small systematic review found no significant differences in balance outcomes between VR and conventional PT, but the authors noted that VR ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1836955323000504

Physiotherapy management of moderate-to-severe ... Virtual reality-based therapy for the treatment of balance deficits in patients receiving inpatient rehabilitation for traumatic brain injury.

5. mdpi.com mdpi.com/2075-1729/15/3/503

Efficacy of Neurorehabilitation Approaches in Traumatic ... Feasibility testing showed accuracy rates of 91.87% for the control group and 78.13% for TBI participants, with all exceeding the 70% usability threshold.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05714150

Study Details | NCT05714150 | Brain Balance Study The first aim of the study is to determine if TBI+ participants have impaired balance, cognition, and oculomotor performance compared to TBI- participants. The ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12202449/

A comprehensive review of rehabilitation approaches for ... Cognitive rehabilitation helps individuals with mild-to-moderate traumatic brain injury (TBI) manage problems with attention, memory, and ...