Level Up! Adaptive Gaming for Children With Upper Limb Differences

NCT ID: NCT05981664

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-06-30

Brief Summary

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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

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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

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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)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

All participants are provided the intervention, and act as their own control when they are evaluated with and without the intervention.

Study Groups

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with adapter

All participants are in the experimental group baseline speed and accuracy using minecraft videogame will serve as baseline data and each subject will be their own control. participants will be given an adapter to support onehanded game play and an xbox system to use at home for a week. Follow-up data (speed and accuracy of minecraft) will be reevaluated one week later. Qualitative interview data will assist in understanding facilitators and barriers for use. On baseline and reassessment, the QUEST 2.0 and VAS will be administered as the primary outcome measures in addition to secondary outcome measures (speed and accuracy of minecraft).

Group Type EXPERIMENTAL

One Handed Video Game Controller Adapter

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rehabilitation Centre for Children, Canada

OTHER

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Meghan Guglich

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Rehabilitation Centre for Children

Locations

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Rehabilitation Centre for Children

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Elizabeth Hammond, PT, PhD

Role: CONTACT

204-451-5702

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

Role: CONTACT

204-258-6673

Facility Contacts

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Elizabeth Hammond

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 29715597 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20704518 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24295515 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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HS25775 (B2022:110)

Identifier Type: -

Identifier Source: org_study_id

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