- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05981664
Level Up! Adaptive Gaming for Children With Upper Limb Differences
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elizabeth Hammond, PT, PhD
- Phone Number: 204-451-5702
- Email: ehammond@rccinc.ca
Study Contact Backup
- Name: Meghan C Guglich, C.P.(c), MSc.
- Phone Number: 204-258-6673
- Email: mguglich@rccinc.ca
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3E 3G1
- Recruiting
- Rehabilitation Centre for Children
-
Contact:
- Elizabeth Hammond
- Email: ehammond@rccinc.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0)
Time Frame: 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").
|
Change in the QUEST (2.0) will be evaluated at baseline, and repeated one week later
|
|
Visual Analog Scale (VAS) for Satisfaction (w/faces scale)
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
|
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.
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to complete obstacle course
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
|
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.
|
Change in time to complete the obstacle course will be recorded for the with and without adapter condition at baseline and one week later
|
|
Errors to complete obstacle course
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
|
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.
|
Change in errors to complete the obstacle course will be completed for the with and without adapter condition at baseline and one week later
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Meghan C Guglich, C.P.(c), MSc., Rehabilitation Centre for Children
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS25775 (B2022:110)
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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