Level Up! Adaptive Gaming for Children With Upper Limb Differences

NCT05981664 | Recruiting

• 1 other identifier: HS25775 (B2022:110)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Time to complete obstacle course

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

• Errors to complete obstacle course

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

Study Arms (1)

with adapter

EXPERIMENTAL

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).

Device: One Handed Video Game Controller Adapter

Interventions

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

with adapter

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Rehabilitation Centre for Children, Canada: collaborator

Study Sites (1)

Rehabilitation Centre for Children

Winnipeg, Manitoba, R3E 3G1, Canada

RECRUITING

Related Publications (3)

• 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.

  PMID: 29715597 BACKGROUND

• 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.

  PMID: 20704518 BACKGROUND

• 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.

  PMID: 24295515 BACKGROUND

MeSH Terms

Conditions

Amniotic Band Syndrome; Wounds and Injuries

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Meghan C Guglich, C.P.(c), MSc.

  Rehabilitation Centre for Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Hammond, PT, PhD

CONTACT

204-451-5702; ehammond@rccinc.ca

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

CONTACT

204-258-6673; mguglich@rccinc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants are provided the intervention, and act as their own control when they are evaluated with and without the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: August 8, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)