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NCT Number: NCT05981664

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

Recruiting

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Key information

Conditions

Upper Limb Amputation at the Wrist Amniotic Band Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Pediatric Upper Limb Amputation Upper Limb Amputation Below Elbow (Injury) Upper Limb Amputation at the Hand Wounds and Injuries

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Centre for Children

Winnipeg, Manitoba, R3E 3G1, Canada

Location status: Recruiting

Location contact

Elizabeth Hammond

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One Handed Video Game Controller Adapter

Device

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

Primary outcomes

  1. Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0)

    Time frame: Change in the QUEST (2.0) will be evaluated at baseline, and repeated one week later

    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").

  2. Visual Analog Scale (VAS) for Satisfaction (w/faces scale)

    Time frame: Change in satisfaction with play experience will be evaluated for both the with and without adapter conditions at baseline, and repeated one week later

    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.

Secondary outcomes

  1. Time to complete obstacle course

    Time frame: Change in time to complete the obstacle course will be recorded for the with and without adapter condition at baseline and one week later

    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.

  2. Errors to complete obstacle course

    Time frame: Change in errors to complete the obstacle course will be completed for the with and without adapter condition at baseline and one week later

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Hammond, PT, PhD

CONTACT

[email protected]

204-451-5702

Meghan C Guglich, C.P.(c), MSc.

CONTACT

[email protected]

204-258-6673

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Rehabilitation Centre for Children, Canada

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 8, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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