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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Traumatic Brain Injury
Intervention Other: Xbox One Kinect Gaming
Enrollment 1
Recruitment Details One Veteran recruited from Polytrauma department of Washington DC VA Medical Center during April 2015.
Pre-assignment Details  
Arm/Group Title Xbox One Kinect Gaming
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15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.

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.

Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Xbox One Kinect Gaming
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15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.

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.

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants
37  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
1.Primary Outcome
Title Dynamic Gait Index (DGI)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xbox One Kinect Gaming
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15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.

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.

Overall Number of Participants Analyzed 1
Median (Standard Deviation)
Unit of Measure: units on a scale
Baseline 12  (0.38)
Intervention 17  (2.28)
Retention 19  (0)
2.Secondary Outcome
Title Limits of Stability (LOS) - Directional Control
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xbox One Kinect Gaming
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 1
Median (Standard Deviation)
Unit of Measure: percentage of accuracy
Baseline 65  (4.64)
Intervention 68  (3.77)
Retention 67  (2.19)
3.Secondary Outcome
Title Heart Rate at End of Mini-game
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xbox One Kinect Gaming
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: Heart beats per minute
1st 5 Interventions 109.13  (12.65)
2nd 5 interventions 102.09  (5.78)
3rd 5 interventions 92.87  (3.07)
4.Secondary Outcome
Title Heart Rate at Beginning of Mini-game
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xbox One Kinect Gaming
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: Heart beats per minute
1st 5 Interventions 90.71  (13.41)
2nd 5 interventions 87.79  (6.80)
3rd 5 interventions 77.95  (5.99)
5.Other Pre-specified Outcome
Title Total Activity Time (TAT)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xbox One Kinect Gaming
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: Minutes
1st 5 interventions 27.13  (2.58)
2nd 5 interventions 32.85  (1.9)
3rd 5 interventions 30.5  (2.82)
6.Other Pre-specified Outcome
Title Time in Therapeutic Heart Rate Range (TTR)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xbox One Kinect Gaming
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: Minutes
1st 5 interventions 48.87  (7.68)
2nd 5 interventions 51.20  (3.67)
3rd 5 interventions 38.33  (9.78)
Time Frame Weeks 13-21
Adverse Event Reporting Description Adverse events were specifically monitored during the intervention phase (weeks 13-21). Safety was a prioritized consideration during this phase as it related to the safety and feasibility of the specific intervention. During baseline and retention phases, the participant underwent repeated assessment though was primarily under free living conditions, with no active intervention, and required minimal monitoring.
 
Arm/Group Title Xbox One Kinect Gaming
Hide Arm/Group Description

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

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.

All-Cause Mortality
Xbox One Kinect Gaming
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Xbox One Kinect Gaming
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Xbox One Kinect Gaming
Affected / at Risk (%)
Total   0/1 (0.00%) 
Small number of subjects; Potentially variable cardiovascular data due to participant lifestyle
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Shane Chanpimol
Organization: Washington DC VA Medical Center
Phone: 202-745-8000 ext 55854
EMail: shane.chanpimol@va.gov
Layout table for additonal information
Responsible Party: Washington D.C. Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02889289     History of Changes
Other Study ID Numbers: 01729
First Submitted: June 28, 2016
First Posted: September 5, 2016
Results First Submitted: October 5, 2016
Results First Posted: June 15, 2017
Last Update Posted: June 15, 2017