Physical DisabilityNCT02994199
Use of Adapted Controllers for Active Video Gaming in People With Physical Disabilities
A study testing Active video gaming in people with Physical Disability, run by University of Alabama at Birmingham.
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. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Physical Disability
- What is being tested?
- Active video gaming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Unstable cardiovascular conditions as identified by their physician.
- Weight over 350 pounds
- Visual impairment that interferes with playing video games
About this study
Official title: Use of Adapted Controllers for Active Video Gaming (Interactive Exercise and Recreation Technologies and Exercise Physiology Benefiting People With Disabilities)
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.
Read the 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.
- Conditions
- Physical Disability
- Being tested
- Active video gaming
- Keywords
- Active video gaming, Energy expenditure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active video gamingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active video gaming | Experimental | Participants will engage in active video game play. Receives: Other: Active video gaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure (ml/kg/min)
Measured using a portable metabolic system
Measured: Visit 1: baseline measurement at rest
Energy expenditure (ml/kg/min)
Measured using a portable metabolic system
Measured: Visit 2: during game play
Energy expenditure (ml/kg/min)
Measured using a portable metabolic system
Measured: Visit 3: during game play
Secondary outcomes (10)
Enjoyment
Participants will complete the Physical Activity Enjoyment Scale (PACES)
Measured: Visit 2: following first game set
Enjoyment
Participants will complete the Physical Activity Enjoyment Scale (PACES)
Measured: Visit 2: following second game set
Enjoyment
Participants will complete the Physical Activity Enjoyment Scale (PACES)
Measured: Visit 3: following first game set
Enjoyment
Participants will complete the Physical Activity Enjoyment Scale (PACES)
Measured: Visit 3: following second game set
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)
Measured: Visit 2: following first game set
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)
Measured: Visit 2: following second game set
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)
Measured: Visit 3: following first game set
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)
Measured: Visit 3: following second game set
Controller usability
Participants will complete the System Usability Scale
Measured: At the completion of Visit 2
Controller usability
Participants will complete the System Usability Scale
Measured: At the completion of Visit 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Laurie A Malone, PhD, University of Alabama at Birmingham
- Investigators
- Sangeetha Padalabalanarayanan, MS, Study director, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994199
- Sponsor's protocol ID
- F150909002
- Status last verified
- Jan 2022
- First submitted
- 6 Dec 2016
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28623186Malone 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.
PubMed 30707098Thirumalai 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.
PubMed 29510972Malone 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.
PubMed 34435962
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Adapted Controllers for Active Video Gaming (Interactive Exercise and Recreation Technologies and Exercise Physiology Benefiting People With Disabilities)
- ClinicalTrials.gov ID
- NCT02994199
- Acronym / sponsor ID
- F150909002
- Conditions
- Physical Disability
- Keywords
- Active video gaming, Energy expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- Jan 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active video gaming | Experimental | Other: Active video gamingParticipants will engage in active video game play. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Unstable cardiovascular conditions as identified by their physician.
- Weight over 350 pounds
- Visual impairment that interferes with playing video games
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active video gamingParticipants 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. | Other | Active video gaming |
Primary outcome
Energy expenditure (ml/kg/min)
Time frame: Visit 1: baseline measurement at rest
Measured using a portable metabolic system
Energy expenditure (ml/kg/min)
Time frame: Visit 2: during game play
Measured using a portable metabolic system
Energy expenditure (ml/kg/min)
Time frame: Visit 3: during game play
Measured using a portable metabolic system
10 secondary outcomes
Enjoyment
Time frame: Visit 2: following first game set
Enjoyment
Time frame: Visit 2: following second game set
Enjoyment
Time frame: Visit 3: following first game set
Enjoyment
Time frame: Visit 3: following second game set
Quality of game play
Time frame: Visit 2: following first game set
Quality of game play
Time frame: Visit 2: following second game set
Quality of game play
Time frame: Visit 3: following first game set
Quality of game play
Time frame: Visit 3: following second game set
Controller usability
Time frame: At the completion of Visit 2
Controller usability
Time frame: At the completion of Visit 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Background: PubMed 28623186Malone 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.
- Results publication: PubMed 30707098Malone 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.
- Results publication: PubMed 29510972Thirumalai 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.
- Results publication: PubMed 34435962Malone 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangeetha Padalabalanarayanan, MS study director
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Active video gaming in people with Physical Disability, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure (ml/kg/min) (time frame: Visit 1: baseline measurement at rest). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02994199, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.