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Trial record 33 of 156 for:    (Dementia pugilistica OR chronic traumatic encephalopathy) AND traumatic brain injury (TBI)

Using the Xbox Kinect for Chronic TBI

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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

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Other: Xbox One Kinect Gaming Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Balance and Endurance Outcomes for Chronic TBI Using the Xbox Kinect
Study Start Date : May 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Xbox One Kinect Gaming
15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889289


Locations
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United States, District of Columbia
Washington DC VA Medical Center
Washington, District of Columbia, United States, 20042
Sponsors and Collaborators
Washington D.C. Veterans Affairs Medical Center
Investigators
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Principal Investigator: Michael Harris-Love, DSc Washington DC VA Medical Center

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Responsible Party: Washington D.C. Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02889289     History of Changes
Other Study ID Numbers: 01729
First Posted: September 5, 2016    Key Record Dates
Results First Posted: June 15, 2017
Last Update Posted: June 15, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Washington D.C. Veterans Affairs Medical Center:
traumatic brain injury
virtual reality
Xbox kinect
balance
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries