- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02994199
Use of Adapted Controllers for Active Video Gaming in People With Physical Disabilities
Use of Adapted Controllers for Active Video Gaming (Interactive Exercise and Recreation Technologies and Exercise Physiology Benefiting People With Disabilities)
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active video gaming
Participants will engage in active video game play.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy expenditure (ml/kg/min)
Time Frame: Visit 1: baseline measurement at rest
|
Measured using a portable metabolic system
|
Visit 1: baseline measurement at rest
|
Energy expenditure (ml/kg/min)
Time Frame: Visit 2: during game play
|
Measured using a portable metabolic system
|
Visit 2: during game play
|
Energy expenditure (ml/kg/min)
Time Frame: Visit 3: during game play
|
Measured using a portable metabolic system
|
Visit 3: during game play
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Enjoyment
Time Frame: Visit 2: following first game set
|
Participants will complete the Physical Activity Enjoyment Scale (PACES)
|
Visit 2: following first game set
|
Enjoyment
Time Frame: Visit 2: following second game set
|
Participants will complete the Physical Activity Enjoyment Scale (PACES)
|
Visit 2: following second game set
|
Enjoyment
Time Frame: Visit 3: following first game set
|
Participants will complete the Physical Activity Enjoyment Scale (PACES)
|
Visit 3: following first game set
|
Enjoyment
Time Frame: Visit 3: following second game set
|
Participants will complete the Physical Activity Enjoyment Scale (PACES)
|
Visit 3: following second game set
|
Quality of game play
Time Frame: Visit 2: following first game set
|
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
|
Quality of game play
Time Frame: Visit 2: following second game set
|
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
|
Quality of game play
Time Frame: Visit 3: following first game set
|
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
|
Quality of game play
Time Frame: Visit 3: following second game set
|
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
|
Controller usability
Time Frame: At the completion of Visit 2
|
Participants will complete the System Usability Scale
|
At the completion of Visit 2
|
Controller usability
Time Frame: At the completion of Visit 3
|
Participants will complete the System Usability Scale
|
At the completion of Visit 3
|
Collaborators and Investigators
Investigators
- Study Director: Sangeetha Padalabalanarayanan, MS, University of Alabama at Birmingham
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- F150909002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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