Trial Outcomes & Findings for Using the Xbox Kinect for Chronic TBI (NCT NCT02889289)

NCT ID: NCT02889289

Last Updated: 2017-06-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: 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
• Results posted on: 2017-06-15

Participant Flow

One Veteran recruited from Polytrauma department of Washington DC VA Medical Center during April 2015.

Participant milestones

Measure	Xbox One Kinect Gaming 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 Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Using the Xbox Kinect for Chronic TBI

Baseline characteristics by cohort

Measure	Xbox One Kinect Gaming n=1 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	37 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Xbox One Kinect Gaming n=1 Participants 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.
Dynamic Gait Index (DGI) Baseline	12 units on a scale Standard Deviation 0.38
Dynamic Gait Index (DGI) Intervention	17 units on a scale Standard Deviation 2.28
Dynamic Gait Index (DGI) Retention	19 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: (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.

Outcome measures

Measure	Xbox One Kinect Gaming n=1 Participants 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.
Limits of Stability (LOS) - Directional Control Baseline	65 percentage of accuracy Standard Deviation 4.64
Limits of Stability (LOS) - Directional Control Intervention	68 percentage of accuracy Standard Deviation 3.77
Limits of Stability (LOS) - Directional Control Retention	67 percentage of accuracy Standard Deviation 2.19

SECONDARY outcome

Timeframe: (Intervention) 2 times per week for 8 weeks

Heart rated recorded using heart monitor and chest strap at the end of each mini-game.

Outcome measures

Measure	Xbox One Kinect Gaming n=1 Participants 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.
Heart Rate at End of Mini-game 1st 5 Interventions	109.13 Heart beats per minute Standard Deviation 12.65
Heart Rate at End of Mini-game 2nd 5 interventions	102.09 Heart beats per minute Standard Deviation 5.78
Heart Rate at End of Mini-game 3rd 5 interventions	92.87 Heart beats per minute Standard Deviation 3.07

SECONDARY outcome

Timeframe: (Intervention) 2 times per week for 8 weeks

Heart rated recorded using heart monitor and chest strap at the beginning of each mini-game.

Outcome measures

Measure	Xbox One Kinect Gaming n=1 Participants 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.
Heart Rate at Beginning of Mini-game 2nd 5 interventions	87.79 Heart beats per minute Standard Deviation 6.80
Heart Rate at Beginning of Mini-game 1st 5 Interventions	90.71 Heart beats per minute Standard Deviation 13.41
Heart Rate at Beginning of Mini-game 3rd 5 interventions	77.95 Heart beats per minute Standard Deviation 5.99

OTHER_PRE_SPECIFIED outcome

Timeframe: (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.

Outcome measures

Measure	Xbox One Kinect Gaming n=1 Participants 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.
Total Activity Time (TAT) 1st 5 interventions	27.13 Minutes Standard Deviation 2.58
Total Activity Time (TAT) 2nd 5 interventions	32.85 Minutes Standard Deviation 1.9
Total Activity Time (TAT) 3rd 5 interventions	30.5 Minutes Standard Deviation 2.82

OTHER_PRE_SPECIFIED outcome

Timeframe: (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.

Outcome measures

Measure	Xbox One Kinect Gaming n=1 Participants 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.
Time in Therapeutic Heart Rate Range (TTR) 1st 5 interventions	48.87 Minutes Standard Deviation 7.68
Time in Therapeutic Heart Rate Range (TTR) 2nd 5 interventions	51.20 Minutes Standard Deviation 3.67
Time in Therapeutic Heart Rate Range (TTR) 3rd 5 interventions	38.33 Minutes Standard Deviation 9.78

Adverse Events

Xbox One Kinect Gaming

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shane Chanpimol

Washington DC VA Medical Center

Phone: 202-745-8000

Email: shane.chanpimol@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place