- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02889289
Using the Xbox Kinect for Chronic TBI
March 28, 2017 updated by: Washington D.C. Veterans Affairs Medical Center
Balance and Endurance Outcomes for Chronic TBI Using the Xbox Kinect
This study will evaluate the potential for improving balance for a single individual with a history of traumatic brain injury (TBI).
The participant will engage in supervised therapy using commercial games on the Xbox Kinect.
This study will also evaluate the viability of improving cardiovascular fitness using this intervention as well.
The investigators hypothesize that balance improvements will occur and that using the Xbox Kinect is a viable way of improving cardiovascular fitness.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Various forms of virtual reality (VR) training have been recently used for rehabilitation of neurological impairments including postural stability and coordination.
Virtual reality training has also been shown to increase motivation and attention through its use of novel goal-directed challenges.
The Xbox Kinect gaming system allows the Veteran to perform challenging full-body and goal-oriented activities.
Balance improvements using laboratory developed games have been demonstrated in those with a history of TBI.
However, the investigators are specifically interested if improvements can be made using commercial games which can be utilized in physical therapy clinics more readily.
Exercise gaming has been shown to provide adequate intensity exercise to improve heart health in the healthy population.
However, such benefits have not yet been investigated using the Xbox Kinect for individuals with a history of TBI.
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20042
- Washington DC VA Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A male or female Veteran participant must have sustained traumatic brain injury greater than 1 year prior to baseline assessments
- Veteran will be between the ages of 18 and 65 years old
Exclusion Criteria:
- Veterans with any cardiac condition that may cause sudden decompensation during cardiovascular testing and training (e.g., severe congestive heart failure and uncontrolled hypertension)
- If Veteran has a significant cardiac history (as defined by American College of Sports Medicine), physician approval will be acquired prior to cardiac stress tests
- Veterans with a previous history of behavioral impairments (e.g., aggression or inappropriate actions) that would preclude participation in standard physical therapy
- Veterans with lower extremity amputation
- Veterans that exhibit greater than mild cognitive impairments as shown by a score 17/30 or less on the Montreal Cognitive Assessment (MoCA).
- Veterans that are unable to stand unsupported for at least 2 minutes
- Veterans that are unable to ambulate on treadmill with bilateral hand support
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Xbox One Kinect Gaming
15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.
|
The Veteran completed 15 sessions of supervised VR training.
Each session lasted between 50 and 60 minutes in total.
The intervention utilized 2 commercially available Xbox One Kinect games called "Shape Up" and "Kinect Sports: Rivals" to challenge both cardiovascular and balance systems.
Each game is composed of mini-games (MG).
Each MG lasted between 1:30 minutes to 4:00 minutes.
Both games were played for approximately 25 minutes during each session.
Rest breaks were allowed as the participant required them.
Guarding by a therapist was provided dependent on the challenge of the game and the participant's abilities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dynamic Gait Index (DGI)
Time Frame: Changes from (Baseline) Weeks 1,2,3,4,6,13,14 to (Intervention) Weeks 1, 3, 4, 6, 8 and to (Retention) Weeks 1, 2, 3, 4, 5
|
The DGI is a common clinical measure used to evaluate dynamic balance and coordination during a person's daily activities.
This test was developed by Shumway-Cook and features 8-items which assess a person's ability to walk while turning their head, changing speed, and navigating obstacles.
The DGI is scored from 0 to 24 where higher scores indicate higher dynamic balance function.
|
Changes from (Baseline) Weeks 1,2,3,4,6,13,14 to (Intervention) Weeks 1, 3, 4, 6, 8 and to (Retention) Weeks 1, 2, 3, 4, 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Limits of Stability (LOS) - Directional Control
Time Frame: (Baseline) Weeks 1,2,3,4,6,13,14; (Intervention) Weeks 1, 3, 4, 6, 8; (Retention) Weeks 1, 2, 3, 4, 5
|
The LOS is performed on the NeuroCom Balance Manager.
The LOS test is a goal-directed weight shifting task.
The LOS-directional control measures the accuracy of an individual's movement of center of gravity during the task compared to a straight line.
This is reported as a percentage without units.
|
(Baseline) Weeks 1,2,3,4,6,13,14; (Intervention) Weeks 1, 3, 4, 6, 8; (Retention) Weeks 1, 2, 3, 4, 5
|
Heart Rate at End of Mini-game
Time Frame: (Intervention) 2 times per week for 8 weeks
|
Heart rated recorded using heart monitor and chest strap at the end of each mini-game.
|
(Intervention) 2 times per week for 8 weeks
|
Heart Rate at Beginning of Mini-game
Time Frame: (Intervention) 2 times per week for 8 weeks
|
Heart rated recorded using heart monitor and chest strap at the beginning of each mini-game.
|
(Intervention) 2 times per week for 8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Activity Time (TAT)
Time Frame: (Intervention) 2 times per week for 8 weeks
|
TAT is a measure of the total time that the Veteran will be participating in mini-game challenges during the 60 minute intervention session.
|
(Intervention) 2 times per week for 8 weeks
|
Time in Therapeutic Heart Rate Range (TTR)
Time Frame: (Intervention) 2 times per week for 8 weeks
|
TTR is the amount of time the Veteran spends within a target heart range of moderate to vigorous exercise prescribed as greater than 40% heart rate reserve.
|
(Intervention) 2 times per week for 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
June 28, 2016
First Submitted That Met QC Criteria
August 30, 2016
First Posted (Estimate)
September 5, 2016
Study Record Updates
Last Update Posted (Actual)
June 15, 2017
Last Update Submitted That Met QC Criteria
March 28, 2017
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01729
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Traumatic Brain Injury
-
Fondazione per la Ricerca Ospedale MaggioreCompletedBrain Injuries, Traumatic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateItaly
-
Toronto Rehabilitation InstituteCentre for Aging and Brain Health Innovation; Ontario Neurotrauma FoundationUnknownBrain Injuries, Traumatic | Brain Injury, Chronic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateCanada
-
Hospital Sirio-LibanesUniversity of Sao Paulo; Ministry of Health, Brazil; Hospital Sao Rafael; PROAD... and other collaboratorsRecruitingBrain Injury Traumatic Severe | Brain Injury Traumatic Moderate | Post Traumatic EpilepsyBrazil
-
University of TurkuTurku University Hospital; The Finnish Funding Agency for Technology and Innovation... and other collaboratorsCompletedBrain Injuries | TBI (Traumatic Brain Injury) | Brain Injuries, Traumatic | Traumatic Brain Injury | Injury, Brain, TraumaticFinland
-
Children's Hospital Medical Center, CincinnatiUniversity of CincinnatiCompletedBrain Injury Traumatic MildUnited States
-
BrainScope Company, Inc.RecruitingTBI (Traumatic Brain Injury) | Concussion, Brain | MTBI - Mild Traumatic Brain Injury | Closed Head InjuryUnited States
-
Institut National de la Santé Et de la Recherche...Institut National de Recherche en Informatique et en AutomatiqueNot yet recruitingTBI (Traumatic Brain Injury)France
-
University of Sao Paulo General HospitalUnknownTraumatic Brain Injury | Severe Brain Injury | Closed Traumatic Brain InjuryBrazil
-
Queen Mary University of LondonCompleted
-
First Affiliated Hospital Xi'an Jiaotong UniversityXijing Hospital; Second Affiliated Hospital of Wenzhou Medical University; Central... and other collaboratorsRecruitingMTBI - Mild Traumatic Brain Injury | Moderate Traumatic Brain InjuryChina
Clinical Trials on Xbox One Kinect Gaming
-
Qassim UniversityCairo UniversityCompletedBurns | Hand BurnEgypt
-
Universidade Federal de GoiasCompletedSleep | Anxiety | Exercise | Aging
-
Riphah International UniversityCompleted
-
Universidad Rey Juan CarlosCompletedCerebral Palsy
-
University Hospital of FerraraCompletedTraumatic Brain Injury | Balance Disorders | Attention DeficitsItaly
-
Ankara Yildirim Beyazıt UniversityCompleted
-
Centre Hospitalier Universitaire de NiceTerminatedDisease AlzheimerNetherlands, France, Australia
-
UnitedHealth GroupCompletedChildhood ObesityUnited States
-
Mehmet SönmezCompletedThe Effects of Non-Immersive Virtual Reality Exercises on Muscle Excitability in Knee OsteoarthritisKnee Osteoarthritis | Virtual RealityTurkey