Neuromuscular Diseases in ChildrenNCT07216339
Gamification Effects on the 6-Minute Walk Test in Children
A study testing Standard 6MWT and Gamified 6MWT in people with Neuromuscular Diseases in Children, run by David Toupin at 1 site in United States.
Trial summary
The goal of this study is to learn if adding a game to the 6-minute walk test for children with neuromuscular disorders will increase enjoyment and motivation to complete the test. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Neuromuscular Diseases in Children
- What is being tested?
- Standard 6MWT and Gamified 6MWT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2026to 30 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of, or active evaluation for, a neuromuscular disorder
- Able to ambulate (with or without usual orthoses/assistive device) sufficiently to attempt a 6-minute walk.
- Note: Acceptable if the patient needs to take breaks or sit during the test. Those unable to finish are counted as protocol deviations, not exclusions.
- Medically stable on the test day (no acute illness or recent surgery that would contraindicate moderate exercise).
- Child able to understand simple instructions in English and provide assent (if applicable based upon age and developmental level); parent/guardian able to provide consent in English.
Who cannot join
- Non-ambulatory or unsafe to attempt walking as judged by the treating physician.
- Severe cognitive/behavioral impairment that precludes following instructions.
- Acute cardiopulmonary, orthopedic, or other medical condition that makes walking unsafe on the test day.
- Non-English-speaking family (materials are available only in English for this pilot).
- Any child/parent who declines consent/assent or withdraws at any time.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
David N Toupin, MD, 859-218-1900, d.n.toupin@uky.edu
About this study
Official title: Effect of Gamification on 6-Minute Walk Test Performance and Engagement in Pediatric Neuromuscular Patients
The goal of this study is to learn if adding a game to the 6-minute walk test for children with neuromuscular disorders will increase enjoyment and motivation to complete the test.
- Conditions
- Neuromuscular Diseases in Children
- Being tested
- Standard 6MWT, Gamified 6MWT
- Keywords
- Gamification, Walk Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard 6MWTOther
ATS-standard instructions, no electronic system; Conducted in hallway measuring total length of 90ft (27.4 meters). Patients will walk down-and-back. A seated rest period of ≥10 min separates the two tests to minimize fatigue carry-over.
Gamified 6MWTOther
identical course but child carries a RFID tag; at each lap the child taps an on an RFID reader, awarding a point and leveling-up an on-screen avatar; Conducted in hallway measuring total length of 90ft (27.4 meters). Patients will walk down-and-back.A seated rest period of ≥10 min separates the two tests to minimize fatigue carry-over.
| Study group | Role | What they receive |
|---|---|---|
| Gamified test | Experimental | child carries a Radio-frequency identification (RFID) tag to scan at each lap, watching avatar level up. Receives: Other: Gamified 6MWT |
| Standard test | Active comparator | no game; same verbal cue every minute Receives: Other: Standard 6MWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 minute walk distance
Participants will walk back and forth in the clinic hallway for 6 minutes and distance will be recorded in meters
Measured: Baseline and post intervention (approximately 20 minutes)
Secondary outcomes (4)
Change in Children's OMNI Rate of Perceived Exertion (RPE) Scale
The OMNI RPE scale is a visual and numerical tool from 0-10 that helps individuals subjectively gauge the intensity of walking or running activity, with 0 representing no effort and 10 being maximal exertion.
Measured: Baseline and post intervention (approximately 20 minutes)
Change in Physical Activity Enjoyment Scale (PACES)
The Physical Activity Enjoyment Scale (PACES) consists of 8 questions scored on a scale from 1 to 7, with a maximum score of 56 and a minimum score of 8. Higher scores indicate greater enjoyment of physical activity.
Measured: Baseline and post intervention (approximately 20 minutes)
Recruitment Rate
percent of eligible participants successfully recruited in the study
Measured: 9 months
Test completion rate
number of walk tests successfully completed compared to overall number of walk tests
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start12 Jun 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular Diseases in ChildrenStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Toupin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Toupin, University of Kentucky
- Investigators
- David N Toupin, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216339
- Sponsor's protocol ID
- 103847
- Status last verified
- Jul 2026
- First submitted
- 10 Oct 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gamification on 6-Minute Walk Test Performance and Engagement in Pediatric Neuromuscular Patients
- ClinicalTrials.gov ID
- NCT07216339
- Acronym / sponsor ID
- 103847
- Conditions
- Neuromuscular Diseases in Children
- Keywords
- Gamification, Walk Test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- David ToupinUniversity, hospital or other
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Oct 2025 (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 study is to learn if adding a game to the 6-minute walk test for children with neuromuscular disorders will increase enjoyment and motivation to complete the test.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gamified test | Experimental | Other: Gamified 6MWTchild carries a Radio-frequency identification (RFID) tag to scan at each lap, watching avatar level up. |
| Standard test | Active comparator | Other: Standard 6MWTno game; same verbal cue every minute |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Clinical diagnosis of, or active evaluation for, a neuromuscular disorder
- Able to ambulate (with or without usual orthoses/assistive device) sufficiently to attempt a 6-minute walk.
- Note: Acceptable if the patient needs to take breaks or sit during the test. Those unable to finish are counted as protocol deviations, not exclusions.
- Medically stable on the test day (no acute illness or recent surgery that would contraindicate moderate exercise).
- Child able to understand simple instructions in English and provide assent (if applicable based upon age and developmental level); parent/guardian able to provide consent in English.
Key exclusion criteria (5 listed)
- Non-ambulatory or unsafe to attempt walking as judged by the treating physician.
- Severe cognitive/behavioral impairment that precludes following instructions.
- Acute cardiopulmonary, orthopedic, or other medical condition that makes walking unsafe on the test day.
- Non-English-speaking family (materials are available only in English for this pilot).
- Any child/parent who declines consent/assent or withdraws at any time.
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 |
|---|---|---|
| Standard 6MWTATS-standard instructions, no electronic system; Conducted in hallway measuring total length of 90ft (27.4 meters). Patients will walk down-and-back. A seated rest period of ≥10 min separates the two tests to minimize fatigue carry-over. | Other | Standard test |
| Gamified 6MWTidentical course but child carries a RFID tag; at each lap the child taps an on an RFID reader, awarding a point and leveling-up an on-screen avatar; Conducted in hallway measuring total length of 90ft (27.4 meters). Patients will walk down-and-back.A seated rest period of ≥10 min separates the two tests to minimize fatigue carry-over. | Other | Gamified test |
Primary outcome
Change in 6 minute walk distance
Time frame: Baseline and post intervention (approximately 20 minutes)
Participants will walk back and forth in the clinic hallway for 6 minutes and distance will be recorded in meters
4 secondary outcomes
Change in Children's OMNI Rate of Perceived Exertion (RPE) Scale
Time frame: Baseline and post intervention (approximately 20 minutes)
Change in Physical Activity Enjoyment Scale (PACES)
Time frame: Baseline and post intervention (approximately 20 minutes)
Recruitment Rate
Time frame: 9 months
Test completion rate
Time frame: 9 months
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 27 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Neuromuscular Diseases in Children
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
RecruitingPhase 2/3
A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
Myasthenia Gravis
Enrolling by invitationPhase 2/3
Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis, gMG
RecruitingPhase 1
Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...
Neurofibroma, Plexiform, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Active, not recruitingPhase 2
Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia
Juvenile Myelomonocytic Leukemia, Neurofibromatosis Type 1
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.
David N Toupin, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard 6MWT and Gamified 6MWT in people with Neuromuscular Diseases in Children, run by David Toupin at 1 site in United States.
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 5 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 27 Jul 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 United States. 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 David N Toupin, MD (859-218-1900, d.n.toupin@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6 minute walk distance (time frame: Baseline and post intervention (approximately 20 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2026.