Upper Limb Amputation at the WristNCT05981664
Level Up! Adaptive Gaming for Children With Upper Limb Differences
A study of Upper Limb Amputation at the Wrist and Pediatric, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Upper Limb Amputation at the Wrist, Pediatric, Upper Limb Amputation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Rehabilitation Centre for Children
Winnipeg, Manitoba, R3E 3G1
Elizabeth Hammond, ehammond@rccinc.ca
About this study
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?
Read more
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
Read the 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.
- 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)
- Being tested
- One Handed Video Game Controller Adapter
- Keywords
- pediatric, upper limb difference, one handed gaming
- Medical subject headings
- Amniotic Band Syndrome, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Handed Video Game Controller AdapterDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: One Handed Video Game Controller Adapter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: Change in errors to complete the obstacle course will be completed for the with and without adapter condition at baseline and one week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Jan 2024
- Primary completion1 Jan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Upper Limb Amputation at the WristStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Rehabilitation Centre for Children, Canada
- Responsible party
- Principal investigator, Meghan Guglich, University of Manitoba
- Investigators
- Meghan C Guglich, C.P.(c), MSc., Principal investigator, Rehabilitation Centre for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981664
- Sponsor's protocol ID
- HS25775 (B2022:110)
- Status last verified
- Oct 2025
- First submitted
- 9 May 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29715597Michielsen 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.
PubMed 20704518Granic 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.
PubMed 24295515
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Level Up! Adaptive Gaming for Children With Upper Limb Differences
- ClinicalTrials.gov ID
- NCT05981664
- Acronym / sponsor ID
- HS25775 (B2022:110)
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Rehabilitation Centre for Children, Canada
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| with adapter | Experimental | Device: One Handed Video Game Controller AdapterAll 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). |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One Handed Video Game Controller AdapterThe 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 | Device | with adapter |
Primary outcome
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").
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.
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 29715597Jurdi 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.
- Background: PubMed 20704518Michielsen 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.
- Background: PubMed 24295515Granic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meghan C Guglich, C.P.(c), MSc. principal investigator
Rehabilitation Centre for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Upper Limb Amputation at the Wrist and Pediatric, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Hammond, PT, PhD (204-451-5702, ehammond@rccinc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05981664, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.