Level Up! Adaptive Gaming for Children With Upper Limb Differences

Pediatric Clinical Trial

Official title:

Level Up! Adaptive Gaming for Children With Upper Limb Differences

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05981664
• Other study ID #: HS25775 (B2022:110)
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: June 2026

Study information

• Verified date: November 2023
• Source: University of Manitoba
• Contact: Elizabeth Hammond, PT, PhD
• Phone: 204-451-5702
• Email: ehammond[@]rccinc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Amniotic Band Syndrome
• Pediatric
• Upper Limb Amputation
• Upper Limb Amputation at the Hand
• Upper Limb Amputation at the Wrist
• Upper Limb Amputation Below Elbow (Injury)

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Rehabilitation Centre for Children, Canada

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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").	Change in the QUEST (2.0) will be evaluated at baseline, and repeated one week later
Primary	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.	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	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.	Change in time to complete the obstacle course will be recorded for the with and without adapter condition at baseline and one week later
Secondary	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.	Change in errors to complete the obstacle course will be completed for the with and without adapter condition at baseline and one week later