CClinicalTrials.gg
CompletedNCT02889289Updated Jun 15, 2017Results posted

Using the Xbox Kinect for Chronic TBI

An interventional study of Xbox One Kinect Gaming in Traumatic Brain Injury, sponsored by Washington D.C. Veterans Affairs Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-06-15.

Sponsored by Washington D.C. Veterans Affairs Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Traumatic Brain Injury

Keywords

  • traumatic brain injury
  • virtual reality
  • Xbox kinect
  • balance
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 1 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Washington D.C. Veterans Affairs Medical Center is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Xbox One Kinect Gaming

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

    Other: Xbox One Kinect Gaming

Interventions

  • OtherXbox 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.

06

What researchers measure

Primary outcomes

  1. 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.

    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 outcomes

  1. 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.

    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

  2. Heart Rate at End of Mini-game

    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

  3. Heart Rate at Beginning of Mini-game

    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 outcomes

  1. Total Activity Time (TAT)

    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

  2. Time in Therapeutic Heart Rate Range (TTR)

    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

07

Results

Posted Jun 15, 2017
Limitations and caveats
Small number of subjects; Potentially variable cardiovascular data due to participant lifestyle

Participant flow

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

Participant flow — Overall Study
MilestoneXbox One Kinect Gaming
Started1
Completed1
Not completed0

Outcome measures

PrimaryDynamic 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.

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
Reported as:
Median · units on a scale
Dynamic Gait Index (DGI)
units on a scaleXbox One Kinect Gaming
Baseline12 ± 0.38
Intervention17 ± 2.28
Retention19 ± 0
SecondaryLimits 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.

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
Reported as:
Median · percentage of accuracy
Limits of Stability (LOS) - Directional Control
percentage of accuracyXbox One Kinect Gaming
Baseline65 ± 4.64
Intervention68 ± 3.77
Retention67 ± 2.19
SecondaryHeart Rate at End of Mini-game

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
Reported as:
Mean · Heart beats per minute
Heart Rate at End of Mini-game
Heart beats per minuteXbox One Kinect Gaming
1st 5 Interventions109.13 ± 12.65
2nd 5 interventions102.09 ± 5.78
3rd 5 interventions92.87 ± 3.07
SecondaryHeart Rate at Beginning of Mini-game

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
Reported as:
Mean · Heart beats per minute
Heart Rate at Beginning of Mini-game
Heart beats per minuteXbox One Kinect Gaming
1st 5 Interventions90.71 ± 13.41
2nd 5 interventions87.79 ± 6.80
3rd 5 interventions77.95 ± 5.99
Other pre-specifiedTotal Activity Time (TAT)

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
Reported as:
Mean · Minutes
Total Activity Time (TAT)
MinutesXbox One Kinect Gaming
1st 5 interventions27.13 ± 2.58
2nd 5 interventions32.85 ± 1.9
3rd 5 interventions30.5 ± 2.82
Other pre-specifiedTime in Therapeutic Heart Rate Range (TTR)

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
Reported as:
Mean · Minutes
Time in Therapeutic Heart Rate Range (TTR)
MinutesXbox One Kinect Gaming
1st 5 interventions48.87 ± 7.68
2nd 5 interventions51.20 ± 3.67
3rd 5 interventions38.33 ± 9.78

Adverse events

Collected over Weeks 13-21. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Xbox One Kinect Gaming—0/1 (0%)0/1 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Xbox One Kinect Gaming
<=18 years0
Between 18 and 65 years1
>=65 years0
Age, Continuous
Age, Continuous(years)Xbox One Kinect Gaming
Mean37 ± 0
Sex: Female, Male
Sex: Female, Male(Participants)Xbox One Kinect Gaming
Female0
Male1
08

Study locations

1 site
  • Washington DC VA Medical Center
    Washington, District of Columbia 20042, United States
09

References and documents

Publications

  • 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. PubMed 28824816 ↗

Individual participant data

Plan to share: Yes

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02889289
Lead sponsor
Washington D.C. Veterans Affairs Medical Center
Responsible party
Sponsor
First posted
Sep 5, 2016
Start date
May 2015
Primary completion
Dec 2015
Completion
Dec 2015
Results posted
Jun 15, 2017
Last update
Jun 15, 2017

Study contacts

Michael Harris-Love, DSc
principal investigator · Washington DC VA Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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