Skip to content

Balance After Traumatic Brain Injury

Aging With a Traumatic Brain Injury: Implications for Balance Deficits and Fall Risk

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05714150
Enrollment
21
Registered
2023-02-06
Start date
2024-03-21
Completion date
2026-06-30
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury, aging, balance, cognition

Brief summary

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.

Detailed description

Accumulating research indicates that a TBI sustained in early or middle adulthood has the potential to influence the trajectory of the aging process, both in the context of brain function and whole-body health. People who consider themselves to be fully recovered and asymptomatic many years following a brain injury might actually exhibit poorer function than peers who did not experience a head injury. The TBI literature reveals compelling evidence that TBI can elicit long-term abnormal cascades of neuroendocrine and neuroinflammatory processes that alter the structural and functional integrity of brain networks. However, there is little direct evidence to establish whether "normal" age-related neurodegeneration and decline of physical and cognitive function are made worse by a TBI that occurred many years earlier. By understanding the chronic effects of "aging with a TBI" the investigators can better identify potential interventions to reduce negative repercussions across the lifespan. This is an important area of investigation, considering there is a substantial window of opportunity for Veterans who have experienced a TBI to engage in rehabilitative interventions and lifestyle modifications that may preserve function as they transition to older age. 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, in order to gain experience for conducting future rehabilitation studies. Veterans with prior TBI (TBI+ group) will be compared to a control group who report no history of TBI (TBI- group). The investigators propose to enroll Veterans who are transitioning into older age (i.e., age between 50-65 years). This study will focus on balance function because of its close association with fall risk. Falls and resultant injuries are a major cause of disability in older Veterans and civilians, which poses a substantial rehabilitation demand and cost to individuals and society. The significance of balance deficits and falls will only grow in the coming years, as more than 50% of all Veterans will be 65 years or older by 2050. Further, loss of balance is very common in the acute stage of recovery from TBI, suggesting damage to neural control pathways/networks that might be susceptible to chronic effects. As secondary outcomes, the investigators will conduct assessments that are related to balance function (including cognitive and oculomotor function) and that increase the risk of injuries due to a fall (bone mineral density). The TBI literature suggests that these secondary outcomes are also susceptible to the chronic effects of a TBI. The first aim of the study is to determine if TBI+ participants have impaired balance, cognition, and oculomotor performance compared to TBI- participants. The second aim of the study is to evaluate the potential for practice-based learning of balance tasks requiring visuospatial cognitive engagement. In addition to the proposed group analyses, the investigators will also conduct exploratory regression analysis within the TBI+ participants to examine potential relationships between the severity of injury and continuous measures of motor and cognitive performance. The knowledge and experience gained from this study will prepare to conduct larger studies to better understand the chronic effects of aging with a TBI, as well as prepare to test rehabilitation interventions to promote healthy aging in this population.

Interventions

BEHAVIORALComplex Balance Tasks

The intervention will consist of a single session of practicing complex (cognitively engaging) balance tasks using an exergaming balance platform.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

The intervention will consist of a single session of practicing complex (cognitively engaging) balance tasks using an exergaming balance platform. The session will include 30 minutes of practice. Participants with TBI history and without TBI history will both complete the same intervention.

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

Enrollment Criteria for Participant with TBI (TBI+ group) Inclusion criteria * Age 50-75. People of this age normally do not exhibit substantial balance or cognitive impairments, so observing a clear deficit between groups will provide compelling evidence of a TBI-related effect. This "younger old" age group will also help to avoid other comorbid health conditions of older age that would increase variability (uncertainty) in the data set. * Prior history of moderate closed-head TBI at least 10 years prior to study enrollment. Single or multiple TBIs are acceptable. All participants who self-report a prior TBI will complete a standardized interview called the Ohio State University TBI Identification Method (OSU TBI-ID) to characterize and confirm the occurrence of a prior moderate TBI. Moderate TBI will be defined as any of the following: * loss of consciousness from 30 minutes to 24 hours * and/or alteration of consciousness/mental state for greater than 24 hours * and/or post-traumatic amnesia for \>1 to \<7 days * and/or abnormal structural imaging confirmed by medical records * Affirmative response to the question: "At the present time, do you consider yourself to be fully recovered from the TBI?" * Score on the Activities Specific Balance Confidence Scale of 90 or higher (out of 100 possible points), which indicates absence of self-reported balance/mobility deficits. * Score of 19 or higher on the telephone version of the Montreal Cognitive Assessment, which indicates absence of major cognitive impairment. * living in the community and able to travel to the research site

Exclusion criteria

Enrollment Criteria for Participant with TBI (TBI+ group)

Design outcomes

Primary

MeasureTime frameDescription
Center of Pressure (COP) controlChange from baseline COP control, measured immediately following a single intervention session (the session will include 30 minutes)Participants will receive real-time feedback of their center of pressure location, by observing a tracing on a television screen. They will shift their body weight in order to move the center of pressure, and will attempt to follow a pre-defined trajectory that is shown on the screen.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDavid J. Clark, DSc

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026