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

NCT02899468 | Completed

• 1 other identifier: 412759
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

TBI; Virtual Reality

Outcome Measures

Primary Outcomes (2)

• 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.

  Clinician Feedback Questionnaire: In order to determine technology feasibility and technology acceptance by the healthcare provider, we will use a subjective evaluation rating questionnaire. The rating will be similar to that used in the subjects' questionnaire, however, questions will differ.

  At the midpoint (3 weeks)

• Feasibility of integration of two side-by-side BBVR systems into the clinical rehabilitation practice at Walter Reed National Military Medical Center.

  Clinician Feedback Questionnaire: In order to determine technology feasibility and technology acceptance by the healthcare provider, we will use a subjective evaluation rating questionnaire. The rating will be similar to that used in the subjects' questionnaire, however, questions will differ.

  At the endpoint (6 weeks)

Secondary Outcomes (11)

• 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)

  At the midpoint (3 weeks) of the active treatment for every participant.

• 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)

  At the endpoint (6 weeks) of the active treatment for every participant.

• Participant cognitive performance

  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.

• Participant motor function (range of motion, strength, and coordination) - Fugl-Meyer Assessment

  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.

• Participant motor function - Jebsen Hand Function Test

  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.

Study Arms (2)

Active Treatment Group

EXPERIMENTAL

Active treatment will consist of the BrightBrainer Virtual Reality (BBVR) Rehabilitation System therapy intervention (3 sessions per week x 6 weeks). Standard validated outcome measures which assess various domains of function, will be obtained at baseline and then at 3 and 6 weeks for those randomized to the Active Treatment group.

Device: BrightBrainer Virtual Reality (BBVR) Rehabilitation System

Wait-List Control Group

OTHER

Subjects randomized to the Wait-List Control (WLC) group will wait 3 weeks before beginning the Active Treatment program intervention (3 sessions per week x 6 weeks) using the BrightBrainer Virtual Reality (BBVR) Rehabilitation System. For those randomized to the WLC group, outcome measures will be assessed at baseline, completion of waiting period (3 weeks), then at 3 and 6 weeks after initiating active treatment.

Device: BrightBrainer Virtual Reality (BBVR) Rehabilitation System

Interventions

BrightBrainer Virtual Reality (BBVR) Rehabilitation System DEVICE

During the active treatment stage (3 sessions per week x 6 weeks), each BBVR therapy session will consist of a series of custom games targeting one or several cognitive domains of executive function, attention, short-term memory, working memory and language comprehension. In addition, the BBVR device incorporates uni- and bi-manual activities by having the subject manipulate hand-held devices, which are programmed to measure in real time the subject's 3D hand movement and index flexion/extension. Therefore, in addition to completing the cognitive tasks, subjects must manipulate virtual hands through a hand-held interface to also enhance visual-motor perception, hand-eye coordination, and upper limb function. In addition, wrist weights can be added to increase upper limb strength training.

Active Treatment Group; Wait-List Control Group

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Bright Cloud International Corp: collaborator
• Walter Reed National Military Medical Center: collaborator
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (1)

• 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.

  PMID: 24679074 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Paul F Pasquina, MD

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 14, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: April 27, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)