Using the Xbox Kinect for Chronic TBI

Traumatic Brain Injury Clinical Trial

Official title:

Balance and Endurance Outcomes for Chronic TBI Using the Xbox Kinect

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02889289
• Other study ID #: 01729
• Status: Completed
• Phase: N/A
• First received: June 28, 2016
• Last updated: August 30, 2016
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Washington D.C. Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Washington DC VA Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Washington D.C. Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	(Intervention) 2 times per week for 8 weeks	No
Other	Time in Therapeutic Heart Rate Range (TTR)	TTR is the amount of time the Veteran spends within the target heart range of moderate exercise prescribed by the 40-60% heart rate reserve calculation.	(Intervention) 2 times per week for 8 weeks	No
Primary	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 has a maximal score of 24.	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	No
Secondary	Limits of Stability (LOS)	The LOS is performed on the NeuroCom Balance Manager. The LOS test is a goal-directed weight shifting task. The LOS measure provides an overall composite score of 5 items recorded during the test and then compared to age-matched norms. This is reported as a relative percentage without units.	(Baseline) Weeks 1,2,3,4,6,13,14; (Intervention) Weeks 1, 3, 4, 6, 8; (Retention) Weeks 1, 2, 3, 4, 5	No
Secondary	Heart rate at beginning and end of mini-game	Heart rated recorded using heart monitor and chest strap at the beginning and end of each mini-game.	(Intervention) 2 times per week for 8 weeks	No
Secondary	Neurology Quality of Life Adult Fatigue Bank (AFB)	The AFB is a patient-reported questionnaire which rates levels of fatigue over the previous week.	(Baseline) Weeks 1,2,3,4,6,13,14; (Intervention) Weeks 1, 3, 4, 6, 8; (Retention) Weeks 1, 2, 3, 4, 5	No
Secondary	Functional Reach Test	The purpose of the FRT is to assess a patient's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position. Three trials are performed where the patient is asked to stand close to, but not touching, a wall and to reach forward with the shoulder flexed to 90 degrees.	(Baseline) Weeks 1,2,3,4,6,13,14; (Intervention) Weeks 1, 3, 4, 6, 8; (Retention) Weeks 1, 2, 3, 4, 5	No