Complex Balance Tasks for Traumatic Brain Injury

Recruiting in Palo Alto (17 mi)

Overseen by David J. Clark, DSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

A moderate traumatic brain injury (TBI) occurring in early or middle adulthood might have long-lasting effects on the brain that can accelerate the decline of physical and cognitive function in older age. The proposed study seeks to better understand the implications of aging with a TBI, in order to help Veterans maintain their health and independence. The overarching hypothesis of this new line of research is that participants who experienced a moderate TBI in early or middle adulthood (at least 15 years prior to study enrollment) will have poorer performance on balance and cognitive tests, despite self-reporting no persistent motor or cognitive impairment from the TBI. The investigators also seek to evaluate the potential for practice-based learning and improvement of complex balance tasks in this population, to gain experience for conducting future rehabilitation studies. The long term goal of this line of research is to design rehabilitative and lifestyle interventions to preserve brain health and function in Veterans who have previously experienced a TBI.

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 data supports the effectiveness of the treatment Complex Balance Tasks, Balance Rehabilitation, Physical Therapy for Balance for traumatic brain injury?

Research shows that physical therapy, including exercises to improve balance and coordination, can help people with traumatic brain injury (TBI) improve their balance. Studies have found improvements in balance and coordination after therapy, as measured by tests like the Berg Balance Scale and Functional Gait Assessment. ^{1 2 3 4 5}

Is Complex Balance Tasks therapy safe for humans?

The research does not provide specific safety data for Complex Balance Tasks therapy, but balance rehabilitation techniques are commonly used in physical therapy and are generally considered safe for humans. ^{1 3 6 7 8}

How is the Complex Balance Tasks treatment different from other treatments for traumatic brain injury?

Complex Balance Tasks treatment is unique because it focuses on improving balance by addressing anticipatory and reactive balance mechanisms, which are often impaired in individuals with traumatic brain injury. This approach targets weight-bearing asymmetries and enhances postural responses, which are not typically the focus of standard physical therapy interventions for TBI. ^{1 2 3 9 10}

Research Team

David J. Clark, DSc

Principal Investigator

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

Eligibility Criteria

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 have completed the OSU TBI-ID test confirming I had a traumatic brain injury.

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

Trial Timeline

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

Treatment Details

Interventions

• Complex Balance Tasks (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of physical therapy interventions on balance ability in people with traumatic brain injury: A systematic review. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Enhancing Anticipatory and Compensatory Postural Responses to Improve Balance in Individuals with TBI. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Objectively assessing balance deficits after TBI: Role of computerized posturography. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Results From a Randomized Controlled Trial to Address Balance Deficits After Traumatic Brain Injury. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Physical therapy for correcting postural and coordination deficits in patients with mild-to-moderate traumatic brain injury. [2014]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Balance impairment in patients with moderate-to-severe traumatic brain injury: Which measures are appropriate for assessment? [2022]

7. England pubmed.ncbi.nlm.nih.gov

Assessment and rehabilitation of central sensory impairments for balance in mTBI using auditory biofeedback: a randomized clinical trial. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

ASSESSING STATIC AND DYNAMIC POSTURAL CONTROL IN A HEALTHY POPULATION. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Spectral analysis of centre of pressure identifies altered balance control in individuals with moderate-severe traumatic brain injury. [2021]

10. England pubmed.ncbi.nlm.nih.gov

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