Clinical trial NCT02889289: Using the Xbox Kinect for Chronic TBI
Official title: Balance and Endurance Outcomes for Chronic TBI Using the Xbox Kinect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
virtual reality
Xbox kinect
balance
Lead sponsor: Washington D.C. Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2016-09-05
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dynamic Gait Index (DGI)
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
Secondary outcomes:
measure: Limits of Stability (LOS) - Directional Control
timeFrame: (Baseline) Weeks 1,2,3,4,6,13,14; (Intervention) Weeks 1, 3, 4, 6, 8; (Retention) Weeks 1, 2, 3, 4, 5
measure: Heart Rate at End of Mini-game
timeFrame: (Intervention) 2 times per week for 8 weeks
measure: Heart Rate at Beginning of Mini-game
timeFrame: (Intervention) 2 times per week for 8 weeks
Other outcomes:
measure: Total Activity Time (TAT)
timeFrame: (Intervention) 2 times per week for 8 weeks
measure: Time in Therapeutic Heart Rate Range (TTR)
timeFrame: (Intervention) 2 times per week for 8 weeks
Locations:
city: Washington
country: United States
facility: Washington DC VA Medical Center
state: District of Columbia
Study officials:
affiliation: Washington DC VA Medical Center
name: Michael Harris-Love, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.