NCT02889289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
9 months until next milestone

Results Posted

Study results publicly available

June 15, 2017

Completed
Last Updated

June 15, 2017

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

June 28, 2016

Results QC Date

October 5, 2016

Last Update Submit

March 28, 2017

Conditions

Keywords

traumatic brain injuryvirtual realityXbox kinectbalance

Outcome Measures

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.

    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 (3)

  • Limits of Stability (LOS) - Directional Control

    (Baseline) Weeks 1,2,3,4,6,13,14; (Intervention) Weeks 1, 3, 4, 6, 8; (Retention) Weeks 1, 2, 3, 4, 5

  • Heart Rate at End of Mini-game

    (Intervention) 2 times per week for 8 weeks

  • Heart Rate at Beginning of Mini-game

    (Intervention) 2 times per week for 8 weeks

Other Outcomes (2)

  • Total Activity Time (TAT)

    (Intervention) 2 times per week for 8 weeks

  • Time in Therapeutic Heart Rate Range (TTR)

    (Intervention) 2 times per week for 8 weeks

Study Arms (1)

Xbox One Kinect Gaming

EXPERIMENTAL

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

Other: Xbox One Kinect Gaming

Interventions

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.

Xbox One Kinect Gaming

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington DC VA Medical Center

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

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Limitations and Caveats

Small number of subjects; Potentially variable cardiovascular data due to participant lifestyle

Results Point of Contact

Title
Dr. Shane Chanpimol
Organization
Washington DC VA Medical Center

Study Officials

  • Michael Harris-Love, DSc

    Washington DC VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2016

First Posted

September 5, 2016

Study Start

May 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 15, 2017

Results First Posted

June 15, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

Locations