NCT05981664

Level Up! Adaptive Gaming for Children With Upper Limb Differences

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-01-01
• Completion: 2026-06-01
• First posted: 2023-08-08
• Last updated: 2025-02-14

Locations

1 site across 1 country: Canada