Clinical trial NCT02994199: Use of Adapted Controllers for Active Video Gaming in People With Physical Disabilities
Official title: Use of Adapted Controllers for Active Video Gaming (Interactive Exercise and Recreation Technologies and Exercise Physiology Benefiting People With Disabilities)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Disability
Keywords: Active video gaming
Energy expenditure
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2016-12-15
Enrollment: 105
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the effectiveness of off-the-shelf (OTS) and adapted game controllers on quality of game play, enjoyment, and energy expenditure during active video gaming in persons with mobility impairments. The controllers to be evaluated include off-the-shelf and adapted gaming mats and off-the-shelf and adapted Wii Fit balance boards.

Detailed description: Previous studies have shown that individuals with disabilities have lower levels of physical activity and fitness and higher levels of obesity compared to their non-disabled peers. Research has also shown that engaging this population in physical activity can be extremely challenging due to physical impairments associated with their disability, as well as fewer opportunities to participate.

Active video games (AVG), also known as exergames, are a category of video games that require much more body motion for successful play than the traditional pushbutton or joystick actions. The recent introduction of motion controlled AVGs allow a much greater variety of physical activity to be part of play. These games hold promise for promoting higher levels of energy expenditure, weight management and fitness. However, many current AVGs are inaccessible or offer limited play options for individuals who are unable to stand, have balance issues, poor motor control, or cannot use their lower body to perform game activities. Making AVGs accessible to people with disabilities offers an innovative approach to overcoming various barriers to participation in beneficial physical activity.

A recent publication by Dr. Rimmer in the Physical Medicine and Rehabilitation journal examining the use of AVGs as a means to increase energy expenditure in non-ambulatory young adults with disabilities suggested that clinically significant increases in energy expenditure could be achieved with AVGs.

Eligibility criteria: Inclusion Criteria:

* Potential participants must have a confirmed diagnosis of lower extremity mobility disability (e.g., spina bifida, cerebral palsy, muscular dystrophy,1 year post spinal cord injury, multiple sclerosis, stroke, or limb loss) with partial or full use of upper extremities and use of an assistive device (manual wheelchair, walker, crutches, or canes) for balance and/or mobility or should have gait deviation.
* Participants must be between the ages of 10 and 60 yrs, and not weigh more than 350 pounds.

Exclusion Criteria:

* Unstable cardiovascular conditions as identified by their physician.
* Weight over 350 pounds
* Visual impairment that interferes with playing video games

Primary outcomes:
measure: Energy expenditure (ml/kg/min)
timeFrame: Visit 1: baseline measurement at rest
measure: Energy expenditure (ml/kg/min)
timeFrame: Visit 2: during game play
measure: Energy expenditure (ml/kg/min)
timeFrame: Visit 3: during game play
Secondary outcomes:
measure: Enjoyment
timeFrame: Visit 2: following first game set
measure: Enjoyment
timeFrame: Visit 2: following second game set
measure: Enjoyment
timeFrame: Visit 3: following first game set
measure: Enjoyment
timeFrame: Visit 3: following second game set
measure: Quality of game play
timeFrame: Visit 2: following first game set
measure: Quality of game play
timeFrame: Visit 2: following second game set
measure: Quality of game play
timeFrame: Visit 3: following first game set
measure: Quality of game play
timeFrame: Visit 3: following second game set
measure: Controller usability
timeFrame: At the completion of Visit 2
measure: Controller usability
timeFrame: At the completion of Visit 3
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Sangeetha Padalabalanarayanan, MS
role: STUDY_DIRECTOR
References:
citation: Malone LA, Padalabalanarayanan S, McCroskey J, Thirumalai M. Assessment of Active Video Gaming Using Adapted Controllers by Individuals With Physical Disabilities: A Protocol. JMIR Res Protoc. 2017 Jun 16;6(6):e116. doi: 10.2196/resprot.7621.
citation: Malone LA, Thirumalai M, Padalabalanarayanan S, Neal WN, Bowman S, Mehta T. Energy Expenditure and Enjoyment During Active Video Gaming Using an Adapted Wii Fit Balance Board in Adults with Physical Disabilities: Observational Study. JMIR Serious Games. 2019 Feb 1;7(1):e11326. doi: 10.2196/11326.
citation: Thirumalai M, Kirkland WB, Misko SR, Padalabalanarayanan S, Malone LA. Adapting the Wii Fit Balance Board to Enable Active Video Game Play by Wheelchair Users: User-Centered Design and Usability Evaluation. JMIR Rehabil Assist Technol. 2018 Mar 6;5(1):e2. doi: 10.2196/rehab.8003.
citation: Malone LA, Davlyatov GK, Padalabalanarayanan S, Thirumalai M. Active Video Gaming Using an Adapted Gaming Mat in Youth and Adults With Physical Disabilities: Observational Study. JMIR Serious Games. 2021 Aug 26;9(3):e30672. doi: 10.2196/30672.