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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xbox One Kinect Gaming | Experimental | 15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | (Baseline) Weeks 1,2,3,4,6,13,14; (Intervention) Weeks 1, 3, 4, 6, 8; (Retention) Weeks 1, 2, 3, 4, 5 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time in Therapeutic Heart Rate Range (TTR) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Harris-Love, DSc | Washington DC VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington DC VA Medical Center | Washington D.C. | District of Columbia | 20042 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28824816 | Derived | 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. |
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One Veteran recruited from Polytrauma department of Washington DC VA Medical Center during April 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 is scored from 0 to 24 where higher scores indicate higher dynamic balance function. | Posted | Median | Standard Deviation | units on a scale | 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 |
|
Weeks 13-21
Adverse events were specifically monitored during the intervention phase (weeks 13-21). Safety was a prioritized consideration during this phase as it related to the safety and feasibility of the specific intervention. During baseline and retention phases, the participant underwent repeated assessment though was primarily under free living conditions, with no active intervention, and required minimal monitoring.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Small number of subjects; Potentially variable cardiovascular data due to participant lifestyle
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shane Chanpimol | Washington DC VA Medical Center | 202-745-8000 | 55854 | shane.chanpimol@va.gov |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Heart Rate at End of Mini-game | Heart rated recorded using heart monitor and chest strap at the end of each mini-game. | (Intervention) 2 times per week for 8 weeks |
| Heart Rate at Beginning of Mini-game | Heart rated recorded using heart monitor and chest strap at the beginning of each mini-game. | (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.
| (Intervention) 2 times per week for 8 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | 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. | Posted | Median | Standard Deviation | percentage of accuracy | (Baseline) Weeks 1,2,3,4,6,13,14; (Intervention) Weeks 1, 3, 4, 6, 8; (Retention) Weeks 1, 2, 3, 4, 5 |
|
|
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| Secondary | Heart Rate at End of Mini-game | Heart rated recorded using heart monitor and chest strap at the end of each mini-game. | Posted | Mean | Standard Deviation | Heart beats per minute | (Intervention) 2 times per week for 8 weeks |
|
|
|
| Secondary | Heart Rate at Beginning of Mini-game | Heart rated recorded using heart monitor and chest strap at the beginning of each mini-game. | Posted | Mean | Standard Deviation | Heart beats per minute | (Intervention) 2 times per week for 8 weeks |
|
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | Minutes | (Intervention) 2 times per week for 8 weeks |
|
|
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | Minutes | (Intervention) 2 times per week for 8 weeks |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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