Level Up! Adaptive Gaming for Children With Upper Limb Differences (NCT05981664) | Clinical Trial Compass
RecruitingNot Applicable
Level Up! Adaptive Gaming for Children With Upper Limb Differences
Canada20 participantsStarted 2024-01-01
Plain-language 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
Who can participate
Age range
7 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0)
Timeframe: Change in the QUEST (2.0) will be evaluated at baseline, and repeated one week later
2
Visual Analog Scale (VAS) for Satisfaction (w/faces scale)
Timeframe: Change in satisfaction with play experience will be evaluated for both the with and without adapter conditions at baseline, and repeated one week later