NCT02994199

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

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

January 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 15, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

December 6, 2016

Last Update Submit

January 31, 2022

Conditions

Physical Disability

Keywords

Active video gamingEnergy expenditure

Outcome Measures

Primary Outcomes (3)

  • Energy expenditure (ml/kg/min)

    Measured using a portable metabolic system

    Visit 1: baseline measurement at rest

  • Energy expenditure (ml/kg/min)

    Measured using a portable metabolic system

    Visit 2: during game play

  • Energy expenditure (ml/kg/min)

    Measured using a portable metabolic system

    Visit 3: during game play

Secondary Outcomes (10)

  • Enjoyment

    Visit 2: following first game set

  • Enjoyment

    Visit 2: following second game set

  • Enjoyment

    Visit 3: following first game set

  • Enjoyment

    Visit 3: following second game set

  • Quality of game play

    Visit 2: following first game set

  • +5 more secondary outcomes

Study Arms (1)

Active video gaming

EXPERIMENTAL

Participants will engage in active video game play.

Other: Active video gaming

Interventions

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.

Active video gaming

Eligibility Criteria

Age10 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 28623186BACKGROUND

  • 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.

    PMID: 30707098RESULT

  • 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.

    PMID: 29510972RESULT

  • 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.

    PMID: 34435962RESULT

MeSH Terms

Interventions

Exergaming

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sangeetha Padalabalanarayanan, MS

    University of Alabama at Birmingham

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2016

First Posted

December 15, 2016

Study Start

January 1, 2016

Primary Completion

September 1, 2016

Study Completion

December 1, 2021

Last Updated

February 15, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share