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Using the Xbox Kinect for Chronic TBI

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Xbox One Kinect Gaming
Sponsored by
Washington D.C. Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury, virtual reality, Xbox kinect, balance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington DC VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Xbox One Kinect Gaming

Arm Description

15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.

Outcomes

Primary Outcome Measures

Dynamic Gait Index (DGI)
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

Limits of Stability (LOS) - Directional Control
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
Heart rated recorded using heart monitor and chest strap at the end of each mini-game.
Heart Rate at Beginning of Mini-game
Heart rated recorded using heart monitor and chest strap at the beginning of each mini-game.

Full Information

First Posted
June 28, 2016
Last Updated
March 28, 2017
Sponsor
Washington D.C. Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02889289
Brief Title
Using the Xbox Kinect for Chronic TBI
Official Title
Balance and Endurance Outcomes for Chronic TBI Using the Xbox Kinect
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington D.C. Veterans Affairs Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
traumatic brain injury, virtual reality, Xbox kinect, balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xbox One Kinect Gaming
Arm Type
Experimental
Arm Description
15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.
Intervention Type
Other
Intervention Name(s)
Xbox One Kinect Gaming
Intervention Description
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 Measure Information:
Title
Dynamic Gait Index (DGI)
Description
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.
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
Secondary Outcome Measure Information:
Title
Limits of Stability (LOS) - Directional Control
Description
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.
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
Title
Heart Rate at End of Mini-game
Description
Heart rated recorded using heart monitor and chest strap at the end of each mini-game.
Time Frame
(Intervention) 2 times per week for 8 weeks
Title
Heart Rate at Beginning of Mini-game
Description
Heart rated recorded using heart monitor and chest strap at the beginning of each mini-game.
Time Frame
(Intervention) 2 times per week for 8 weeks
Other Pre-specified Outcome Measures:
Title
Total Activity Time (TAT)
Description
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 Frame
(Intervention) 2 times per week for 8 weeks
Title
Time in Therapeutic Heart Rate Range (TTR)
Description
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.
Time Frame
(Intervention) 2 times per week for 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Harris-Love, DSc
Organizational Affiliation
Washington DC VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington DC VA Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20042
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
28824816
Citation
Chanpimol S, Seamon B, Hernandez H, Harris-Love M, Blackman MR. Using Xbox kinect motion capture technology to improve clinical rehabilitation outcomes for balance and cardiovascular health in an individual with chronic TBI. Arch Physiother. 2017;7:6. doi: 10.1186/s40945-017-0033-9. Epub 2017 May 31.
Results Reference
derived

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Using the Xbox Kinect for Chronic TBI

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