Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Using the Xbox Kinect for Chronic TBI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02889289
Recruitment Status : Completed
First Posted : September 5, 2016
Results First Posted : June 15, 2017
Last Update Posted : June 15, 2017
Sponsor:
Information provided by (Responsible Party):
Washington D.C. Veterans Affairs Medical Center

Tracking Information
First Submitted Date  ICMJE June 28, 2016
First Posted Date  ICMJE September 5, 2016
Results First Submitted Date  ICMJE October 5, 2016
Results First Posted Date  ICMJE June 15, 2017
Last Update Posted Date June 15, 2017
Study Start Date  ICMJE May 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2016)
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 has a maximal score of 24.
Change History Complete list of historical versions of study NCT02889289 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2016)
  • Limits of Stability (LOS) [ 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 measure provides an overall composite score of 5 items recorded during the test and then compared to age-matched norms. This is reported as a relative percentage without units.
  • Heart rate at beginning and 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 beginning and end of each mini-game.
  • Neurology Quality of Life Adult Fatigue Bank (AFB) [ 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 AFB is a patient-reported questionnaire which rates levels of fatigue over the previous week.
  • Functional Reach Test [ 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 purpose of the FRT is to assess a patient's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position. Three trials are performed where the patient is asked to stand close to, but not touching, a wall and to reach forward with the shoulder flexed to 90 degrees.
Current Other Pre-specified Outcome Measures
 (submitted: March 28, 2017)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: August 30, 2016)
  • 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.
  • 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 the target heart range of moderate exercise prescribed by the 40-60% heart rate reserve calculation.
 
Descriptive Information
Brief Title  ICMJE Using the Xbox Kinect for Chronic TBI
Official Title  ICMJE Balance and Endurance Outcomes for Chronic TBI Using the Xbox Kinect
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE Other: Xbox One Kinect Gaming
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.
Study Arms  ICMJE Experimental: Xbox One Kinect Gaming
15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.
Intervention: Other: Xbox One Kinect Gaming
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2016)
1
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02889289
Other Study ID Numbers  ICMJE 01729
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Washington D.C. Veterans Affairs Medical Center
Study Sponsor  ICMJE Washington D.C. Veterans Affairs Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Harris-Love, DSc Washington DC VA Medical Center
PRS Account Washington D.C. Veterans Affairs Medical Center
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP