Clinical trial NCT02899468: Evaluation of a Novel Integrative and Intensive Virtual Rehabilitation Program for Service Members Post TBI
Official title: Evaluation of a Novel Integrative and Intensive Virtual Rehabilitation Program for Service Members Post TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: TBI
Virtual Reality
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: Bright Cloud International Corp
name: Walter Reed National Military Medical Center
name: Uniformed Services University of the Health Sciences
First posted: 2016-09-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of integration of two side-by-side BrightBrainer Virtual Reality (BBVR) Rehabilitation Systems into the clinical rehabilitation practice at Walter Reed National Military Medical Center.
timeFrame: At the midpoint (3 weeks)
measure: Feasibility of integration of two side-by-side BBVR systems into the clinical rehabilitation practice at Walter Reed National Military Medical Center.
timeFrame: At the endpoint (6 weeks)
Secondary outcomes:
measure: Subject and clinician acceptance of the BBVR system (ease of use, ease of set up and monitoring, ease of data report production, ease of monitoring two subjects simultaneously)
timeFrame: At the midpoint (3 weeks) of the active treatment for every participant.
measure: Subject and clinician acceptance of the BBVR system (ease of use, ease of set up and monitoring, ease of data report production, ease of monitoring two subjects simultaneously)
timeFrame: At the endpoint (6 weeks) of the active treatment for every participant.
measure: Participant cognitive performance
timeFrame: Change in performance from baseline to completion of the wait-list (for the wait-list control group only), and end point (6 weeks) of active treatment.
measure: Participant motor function (range of motion, strength, and coordination) - Fugl-Meyer Assessment
timeFrame: Change in functional performance from baseline to completion of the wait-list (for the wait-list control group only), and end point (6 weeks) of active treatment.
measure: Participant motor function - Jebsen Hand Function Test
timeFrame: Change in functional performance from baseline to completion of the wait-list (for the wait-list control group only), and end point (6 weeks) of active treatment.
measure: Participant motor function - Box and Blocks Test
timeFrame: Change in functional performance from baseline to completion of the wait-list (for the wait-list control group only), and end point (6 weeks) of active treatment.
measure: Participant functional performance
timeFrame: Change in functional performance over the course of active treatment.
measure: Participant symptoms
timeFrame: Change in symptom reporting from baseline to of the wait-list (for the wait-list control group only), midpoint (3 weeks) of active therapy, and end point (6 weeks) of active treatment.
measure: Participant symptoms
timeFrame: Change in symptom reporting from baseline to of the wait-list (for the wait-list control group only), midpoint (3 weeks) of active therapy, and end point (6 weeks) of active treatment.
measure: Participant symptoms
timeFrame: Change in symptom reporting from baseline to of the wait-list (for the wait-list control group only), midpoint (3 weeks) of active therapy, and end point (6 weeks) of active treatment.
measure: Reliability of the BBVR technology when deployed in a clinical setting
timeFrame: Throughout the duration of the study - expected to last one year.
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Walter Reed National Military Medical Center
name: Paul F Pasquina, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burdea G, Polistico K, Krishnamoorthy A, House G, Rethage D, Hundal J, Damiani F, Pollack S. Feasibility study of the BrightBrainer integrative cognitive rehabilitation system for elderly with dementia. Disabil Rehabil Assist Technol. 2015;10(5):421-32. doi: 10.3109/17483107.2014.900575. Epub 2014 Mar 29.