Pediatric Clinical Trial
Official title:
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
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | Rehabilitation Centre for Children, Canada |
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
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 |
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