Clinical trial NCT05981664: Level Up! Adaptive Gaming for Children With Upper Limb Differences
Official title: Level Up! Adaptive Gaming for Children With Upper Limb Differences
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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)
Keywords: pediatric
upper limb difference
one handed gaming
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Rehabilitation Centre for Children, Canada
First posted: 2023-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: 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
Secondary outcomes:
measure: Time to complete obstacle course
timeFrame: Change in time to complete the obstacle course will be recorded for the with and without adapter condition at baseline and one week later
measure: Errors to complete obstacle course
timeFrame: Change in errors to complete the obstacle course will be completed for the with and without adapter condition at baseline and one week later
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Rehabilitation Centre for Children
state: Manitoba
Study officials:
affiliation: Rehabilitation Centre for Children
name: Meghan C Guglich, C.P.(c), MSc.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.