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Level Up! Adaptive Gaming for Children With Upper Limb Differences

Primary Purpose

Upper Limb Amputation at the Wrist, Pediatric, Upper Limb Amputation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
One Handed Video Game Controller Adapter
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Upper Limb Amputation at the Wrist focused on measuring pediatric, upper limb difference, one handed gaming

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: between the age of 7 and 17 years has a unilateral limb difference limb difference may be from any cause (congenital difference, traumatic loss, etc.) limb difference may be of any level (partial hand, wrist disarticulation, transradial, elbow disarticulation, transhumeral, shoulder disarticulation) ability to communicate in English cognitive ability to follow instructions eligible participants will be included regardless of history of prosthesis use lives locally (Winnipeg) or willing and able to travel to Rehabilitation Centre for Children for 2 appointments Exclusion Criteria: less than 7 or greater than 17 years of age bilateral or no limb upper limb difference inability to communicate in English cognitive inability to follow instructions unable or unwilling to attend 2 appointments at Rehabilitation Centre for Children

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    with adapter

    Arm Description

    All participants are in the experimental group baseline speed and accuracy using minecraft videogame will serve as baseline data and each subject will be their own control. participants will be given an adapter to support onehanded game play and an xbox system to use at home for a week. Follow-up data (speed and accuracy of minecraft) will be reevaluated one week later. Qualitative interview data will assist in understanding facilitators and barriers for use. On baseline and reassessment, the QUEST 2.0 and VAS will be administered as the primary outcome measures in addition to secondary outcome measures (speed and accuracy of minecraft).

    Outcomes

    Primary Outcome Measures

    Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0)
    The QUEST 2.0 is an instrument designed to evaluate user satisfaction with a variety of assistive technologies. Each item in the measure is ranked by the participant on a scale of satisfaction (5 points from "not satisfied at all" to "very satisfied").
    Visual Analog Scale (VAS) for Satisfaction (w/faces scale)
    The VAS is a 10cm horizontal line, faces below it to indicate high to low satisfaction. The participant will mark how satisfied with their experience they are by placing an X on the corresponding position on the line.

    Secondary Outcome Measures

    Time to complete obstacle course
    A standardized video game based obstacle course will be performed in the with and without adapter condition. Time to complete in each condition will be recorded.
    Errors to complete obstacle course
    A standardized video game based obstacle course will be performed in the with and without adapter condition and errors in completion will be counted by an observer.

    Full Information

    First Posted
    May 9, 2023
    Last Updated
    October 22, 2023
    Sponsor
    University of Manitoba
    Collaborators
    Rehabilitation Centre for Children, Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05981664
    Brief Title
    Level Up! Adaptive Gaming for Children With Upper Limb Differences
    Official Title
    Level Up! Adaptive Gaming for Children With Upper Limb Differences
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Manitoba
    Collaborators
    Rehabilitation Centre for Children, Canada

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to test a new one-handed video game controller adapter to determine if it helps improve how video games are played and enjoyed in children with an upper limb difference on one side. The main questions it aims to answer are: Is performance improved while playing video games with the adapter? Is user satisfaction or enjoyment improved while playing video games with the adapter? Participants will: Answer questions about their limb difference and other demographics Be interviewed about their current and past video game playing experiences Learn how to use the adapter and have their performance with it evaluated Take the adapter home to use for 1 week, and be asked to record their experiences Have their performance with the adapter re-evaluated after a week of practice Be interviewed about their experience with the adapter
    Detailed Description
    Each participant will provide informed consent before participating in any study related activities. At initial evaluation, each participant will complete a demographic questionnaire, as well as a semi-structured interview about their previous video game playing experiences, and their motivation to participate in playing video games in the future. Following this interview, they will receive a training session from a team member on how to use the adapter and how to play Minecraft. This video game was chosen for its age appropriateness and need to use almost every button on the controller. Following the training, the investigators will collect initial outcome measure data for both the with and without adapter conditions. Following the initial evaluation appointment, the participant will take home a tracking log, the video game controller adapter, and an Xbox with an Xbox One controller (if they do not already have one at home). Each participant will be asked to use the device daily and fill out the tracking log daily for 7 days. After which, each participant will return to RCC for the final evaluation appointment. At this time, outcome measurement will be repeated for gameplay with and without the adapter conditions. Finally, an exit semi-structured interview will be conducted to evaluate their experience with the adapter. Each participant will return the Xbox and controller if they were taken home. They will have the opportunity to keep the adapter if they wish.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Upper Limb Amputation at the Wrist, Pediatric, Upper Limb Amputation, Upper Limb Amputation at the Hand, Amniotic Band Syndrome, Upper Limb Amputation Below Elbow (Injury)
    Keywords
    pediatric, upper limb difference, one handed gaming

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Masking Description
    All participants are provided the intervention, and act as their own control when they are evaluated with and without the intervention.
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    with adapter
    Arm Type
    Experimental
    Arm Description
    All participants are in the experimental group baseline speed and accuracy using minecraft videogame will serve as baseline data and each subject will be their own control. participants will be given an adapter to support onehanded game play and an xbox system to use at home for a week. Follow-up data (speed and accuracy of minecraft) will be reevaluated one week later. Qualitative interview data will assist in understanding facilitators and barriers for use. On baseline and reassessment, the QUEST 2.0 and VAS will be administered as the primary outcome measures in addition to secondary outcome measures (speed and accuracy of minecraft).
    Intervention Type
    Device
    Intervention Name(s)
    One Handed Video Game Controller Adapter
    Intervention Description
    The one handed video game controller adapter was designed and 3D printed at Rehabilitation Centre for Children. It is a simple model that snaps onto an XBox One controller and uses a series of levers to allow access to almost all buttons of the controller from one side. There is both left and right sided versions
    Primary Outcome Measure Information:
    Title
    Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0)
    Description
    The QUEST 2.0 is an instrument designed to evaluate user satisfaction with a variety of assistive technologies. Each item in the measure is ranked by the participant on a scale of satisfaction (5 points from "not satisfied at all" to "very satisfied").
    Time Frame
    Change in the QUEST (2.0) will be evaluated at baseline, and repeated one week later
    Title
    Visual Analog Scale (VAS) for Satisfaction (w/faces scale)
    Description
    The VAS is a 10cm horizontal line, faces below it to indicate high to low satisfaction. The participant will mark how satisfied with their experience they are by placing an X on the corresponding position on the line.
    Time Frame
    Change in satisfaction with play experience will be evaluated for both the with and without adapter conditions at baseline, and repeated one week later
    Secondary Outcome Measure Information:
    Title
    Time to complete obstacle course
    Description
    A standardized video game based obstacle course will be performed in the with and without adapter condition. Time to complete in each condition will be recorded.
    Time Frame
    Change in time to complete the obstacle course will be recorded for the with and without adapter condition at baseline and one week later
    Title
    Errors to complete obstacle course
    Description
    A standardized video game based obstacle course will be performed in the with and without adapter condition and errors in completion will be counted by an observer.
    Time Frame
    Change in errors to complete the obstacle course will be completed for the with and without adapter condition at baseline and one week later

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: between the age of 7 and 17 years has a unilateral limb difference limb difference may be from any cause (congenital difference, traumatic loss, etc.) limb difference may be of any level (partial hand, wrist disarticulation, transradial, elbow disarticulation, transhumeral, shoulder disarticulation) ability to communicate in English cognitive ability to follow instructions eligible participants will be included regardless of history of prosthesis use lives locally (Winnipeg) or willing and able to travel to Rehabilitation Centre for Children for 2 appointments Exclusion Criteria: less than 7 or greater than 17 years of age bilateral or no limb upper limb difference inability to communicate in English cognitive inability to follow instructions unable or unwilling to attend 2 appointments at Rehabilitation Centre for Children
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elizabeth Hammond, PT, PhD
    Phone
    204-451-5702
    Email
    ehammond@rccinc.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Meghan C Guglich, C.P.(c), MSc.
    Phone
    204-258-6673
    Email
    mguglich@rccinc.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Meghan C Guglich, C.P.(c), MSc.
    Organizational Affiliation
    Rehabilitation Centre for Children
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29715597
    Citation
    Jurdi S, Montaner J, Garcia-Sanjuan F, Jaen J, Nacher V. A systematic review of game technologies for pediatric patients. Comput Biol Med. 2018 Jun 1;97:89-112. doi: 10.1016/j.compbiomed.2018.04.019. Epub 2018 Apr 25.
    Results Reference
    background
    PubMed Identifier
    20704518
    Citation
    Michielsen A, Van Wijk I, Ketelaar M. Participation and quality of life in children and adolescents with congenital limb deficiencies: A narrative review. Prosthet Orthot Int. 2010 Dec;34(4):351-61. doi: 10.3109/03093646.2010.495371. Epub 2010 Aug 13.
    Results Reference
    background
    PubMed Identifier
    24295515
    Citation
    Granic I, Lobel A, Engels RC. The benefits of playing video games. Am Psychol. 2014 Jan;69(1):66-78. doi: 10.1037/a0034857. Epub 2013 Dec 2.
    Results Reference
    background

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