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

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ClinicalTrials.gov Identifier: NCT02366442
Recruitment Status : Unknown
Verified February 2015 by Dr. Azadeh M. Leland, Washington D.C. Veterans Affairs Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 19, 2015
Last Update Posted : February 19, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Azadeh M. Leland, Washington D.C. Veterans Affairs Medical Center

Brief 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

Condition or disease Intervention/treatment
Traumatic Brain Injury TBI Other: Exploring relationships among balance performance, cognitive dysfunction, affective dysregulation, and community integration in Veterans with Traumatic Brain Injury (TBI).

Detailed 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.


Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Exploring Relationships Among Balance Performance, Cognitive Dysfunction, Affective Dysregulation, and Community Integration in Veterans With Traumatic Brain Injury (TBI)
Study Start Date : February 2015
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Exploring relationships among balance performance, cognitive dysfunction, affective dysregulation, and community integration in Veterans with Traumatic Brain Injury (TBI). [ Time Frame: 1-2 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Veterans with the diagnosis of TBI
Criteria

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.


Responsible Party: Dr. Azadeh M. Leland, Fellow at polytrauma/TBI at DCVAMC, Washington D.C. Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02366442     History of Changes
Other Study ID Numbers: WashingtonVAMC
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: February 19, 2015
Last Verified: February 2015

Keywords provided by Dr. Azadeh M. Leland, Washington D.C. Veterans Affairs Medical Center:
dual/multitasking
Executive function
Affective function
Balance

Additional relevant MeSH terms:
Central Nervous System Diseases
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Cognitive Dysfunction
Brain Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Cognition Disorders
Neurocognitive Disorders
Mental Disorders