Exploring Relationships Among Balance Performance, Cognitive Dysfunction, Affective Dysregulation, and Community Integration in Veterans With Traumatic Brain Injury (TBI)

Traumatic Brain Injury Clinical Trial

Official title:

Exploring Relationships Among Balance Performance, Cognitive Dysfunction, Affective Dysregulation, and Community Integration in Veterans With Traumatic Brain Injury (TBI)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02366442
• Other study ID #: WashingtonVAMC
• Status: Not yet recruiting
• Phase: N/A
• First received: February 11, 2015
• Last updated: February 18, 2015
• Start date: February 2015
• Est. completion date: October 2015

Study information

• Verified date: February 2015
• Source: Washington D.C. Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

The overarching goal of the proposed study, named SYNERGY, is to explore relationships among balance performance, cognitive function, affective dysregulation, as they relate to the community re-integration in Veterans with TBI. The SYNERGY study findings can aid in the development of a better outcome models for the clinicians in facilitating effective community re-integration in Veterans with TBI

Description:

Examine if there are associations among balance, cognitive and affective function during multitasking activities in Veterans with the diagnosis of TBI.

To determine if an association exists between balance performance and the degree of community re-integration in Veterans with TBI.

To determine which of the three systems, balance performance, cognitive dysfunction or affective dysregulation, is the strongest predictor of community re-integration in Veterans with TBI.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Exclusion-inclusion criteria Inclusion Criteria: Enrolled participants will be Veterans with TBI between18 to55 years of age. We identified a wide age range in order to include Veterans from the Iraq and Afghanistan conflicts, as well as Veterans of the Vietnam War. This feature of the inclusion criteria is important since barriers to community re-integration may be affected by impaired balance, cognitive dysfunction, affective dysregulation, across the age spectrum. Consequently, the study findings will potentially benefit not only young Veterans, but also middle aged Veterans.

The Military Acute Concussion Evaluation (MACE): We will use MACE scores of 21/30 to ensure the participants have the cognitive ability to understand our study protocol, and therefore, participate voluntarily in the study. 62 Exclusion Criteria: We will use an exclusion criteria of 12/24 on the Dynamic gait index (DGI) to ensure that patients are ambulatory either with or without the use of assistive device to be able to measure dynamic balance accurately.16 Past Medical History: The following diagnoses will be cause for exclusion -- peripheral neuropathy, Parkinson syndromes, multiple sclerosis; bipolar, schizophrenia, seizure or psychiatric illnesses.

Medically stable patients: It is essential to minimize future medical adverse conditions and minimize the risk of drop out. Therefore, no patient shall be considered for enrollment if they do not meet inclusion/exclusion criteria or have not been recommended by the polytrauma staff at VA DCMC.

The result of VHA TBI Comprehensive Evaluation electronic template will be reviewed following IRB approved and HIPAA compliant data collection procedures. The TBI diagnosis will be obtained from patient's chart review of problem section and physician's notes.

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Cognition Disorders
• TBI
• Traumatic Brain Injury

Intervention

Other:
• Exploring relationships among balance performance, cognitive dysfunction, affective dysregulation, and community integration in Veterans with Traumatic Brain Injury (TBI).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington D.C. Veterans Affairs Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exploring relationships among balance performance, cognitive dysfunction, affective dysregulation, and community integration in Veterans with Traumatic Brain Injury (TBI).		1-2 year	Yes