Evaluation of a Novel Integrative and Intensive Virtual Rehabilitation Program for Service Members Post TBI



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 67
Updated:4/29/2018
Start Date:January 2016
End Date:October 2017

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The purpose of the study is to evaluate the feasibility and effectiveness of a novel virtual
reality (VR) therapeutic rehabilitative device (BrightBrainerTM) to treat patients with
traumatic brain injury (TBI). These patients, service members with TBI, can be both with and
without upper limb dysfunction and use uni- and bimanual virtual reality (VR) exercises to
improve cognitive and motor function, as well as mood.

Bright Cloud International Corp created BrightBrainer, a computerized virtual reality system
that provides a combination of cognitive as well as motor skill training in an engaging and
repetitive manner [1]. This project objective is to assess the feasibility and clinical
benefit of utilizing the BBVR to augment the rehabilitation of service members with TBI. The
BrightBrainerTM Virtual Reality (BBVR) Rehabilitation System is unique because it is designed
to provide integrative, customized, intensive and self-guided therapy that simultaneously
addresses the cognitive, emotive and motor deficits. Early evidence suggests that it has been
effective for patients with cognitive deficits as the result of cerebrovascular accident or
dementia, but has not yet been evaluated in a therapeutic intervention for patients with TBI.
In addition to assessing the system's effect on patient's symptoms, we will also evaluate the
feasibility of utilizing this system in a military environment by obtaining feedback from the
patients and therapists, regarding system acceptance, reliability and ease of use.

Inclusion Criteria:

- Male or female military health care beneficiaries 18-67 years of age;

- Presence of TBI (based on standard Veterans Affairs (VA)/ Department of Defense (DoD)
criteria);

- With or without upper extremity dysfunction. Upper extremity dysfunction includes but
is not limited to decreased coordination, increased tone, decreased strength, and
decreased sensation;

- Ability to follow study instructions and likely to complete all required visits for
the study;

- Ability to understand spoken and written English;

- At least 6 weeks post TBI.

Exclusion Criteria:

- Age less than 18 or greater than 67;

- Blind or otherwise visually impaired to the extent that lack of sight inhibits
utilizing the system;

- Deafness;

- Inability to understand or comprehend consenting to the study;

- Active psychosis, suicidal or homicidal ideations or frequent violent episodes;

- Currently enrolled in active substance abuse treatment

- Inability to even minimally operate BBVR controllers.
We found this trial at
1
site
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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mi
from
Bethesda, MD
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