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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02994199
Other study ID # F150909002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date December 2021

Study information

Verified date January 2022
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date December 2021
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 10 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Active video gaming
Participants will engage in active video game play using two off-the-shelf (OTS) and two adapted controllers using the Wii gaming console. Controllers are: OTS balance board, OTS gaming mat, Adapted balance board, Adapted gaming mat.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Alabama at Birmingham National Institute on Disability, Independent Living, and Rehabilitation Research

References & Publications (4)

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. — View 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. — View 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. 2 — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Energy expenditure (ml/kg/min) Measured using a portable metabolic system Visit 1: baseline measurement at rest
Primary Energy expenditure (ml/kg/min) Measured using a portable metabolic system Visit 2: during game play
Primary Energy expenditure (ml/kg/min) Measured using a portable metabolic system Visit 3: during game play
Secondary Enjoyment Participants will complete the Physical Activity Enjoyment Scale (PACES) Visit 2: following first game set
Secondary Enjoyment Participants will complete the Physical Activity Enjoyment Scale (PACES) Visit 2: following second game set
Secondary Enjoyment Participants will complete the Physical Activity Enjoyment Scale (PACES) Visit 3: following first game set
Secondary Enjoyment Participants will complete the Physical Activity Enjoyment Scale (PACES) Visit 3: following second game set
Secondary Quality of game play Subjective evaluation by the tester: degree of general game manipulation in comparison to able-bodied gamer; Likert scale 0 (unable) to 5 (excellent) Visit 2: following first game set
Secondary Quality of game play Subjective evaluation by the tester: degree of general game manipulation in comparison to able-bodied gamer; Likert scale 0 (unable) to 5 (excellent) Visit 2: following second game set
Secondary Quality of game play Subjective evaluation by the tester: degree of general game manipulation in comparison to able-bodied gamer; Likert scale 0 (unable) to 5 (excellent) Visit 3: following first game set
Secondary Quality of game play Subjective evaluation by the tester: degree of general game manipulation in comparison to able-bodied gamer; Likert scale 0 (unable) to 5 (excellent) Visit 3: following second game set
Secondary Controller usability Participants will complete the System Usability Scale At the completion of Visit 2
Secondary Controller usability Participants will complete the System Usability Scale At the completion of Visit 3
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