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Level Up! Adaptive Gaming for Children With Upper Limb Differences

Sponsor
University of Manitoba (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05981664
Collaborator
Rehabilitation Centre for Children, Canada (Other)
20
Enrollment
1
Arm
10
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: One Handed Video Game Controller Adapter
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention 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.
Primary Purpose:
Supportive Care
Official Title:
Level Up! Adaptive Gaming for Children With Upper Limb Differences
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: with adapter

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).

Device: One Handed Video Game Controller Adapter
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

Outcome Measures

Primary Outcome Measures

  1. Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) [Change in the QUEST (2.0) will be evaluated at baseline, and repeated one week later]

    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").

  2. Visual Analog Scale (VAS) for Satisfaction (w/faces scale) [Change in satisfaction with play experience will be evaluated for both the with and without adapter conditions at baseline, and repeated one week later]

    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

  1. Time to complete obstacle course [Change in time to complete the obstacle course will be recorded for the with and without adapter condition at baseline and one week later]

    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.

  2. Errors to complete obstacle course [Change in errors to complete the obstacle course will be completed for the with and without adapter condition at baseline and one week later]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Manitoba
  • Rehabilitation Centre for Children, Canada

Investigators

  • Principal Investigator: Meghan C Guglich, C.P.(c), MSc., Rehabilitation Centre for Children

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Meghan Guglich, Principal Investigator, University of Manitoba
ClinicalTrials.gov Identifier:
NCT05981664
Other Study ID Numbers:
  • HS25775 (B2022:110)
First Posted:
Aug 8, 2023
Last Update Posted:
Aug 8, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 8, 2023