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OpenTrials
Completed

NCT Number: NCT02889289

Using the Xbox Kinect for Chronic TBI

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington DC VA Medical Center

Washington D.C., District of Columbia, 20042, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xbox One Kinect Gaming

Other

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Washington D.C. Veterans Affairs Medical Center

Fed

Registry information

Official study title

Balance and Endurance Outcomes for Chronic TBI Using the Xbox Kinect

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 5, 2016
Registry last updated
Jun 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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