Recruiting

Observational Study

Sponsor:

David Toupin

Code:

NCT07216339

Conditions

Neuromuscular Diseases in Children

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Not accepted

Interventions

Standard 6MWT

Gamified 6MWT

Study Details

Brief 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.

Conditions

Neuromuscular Diseases in Children

Study ID

NCT07216339

Start date

Jun 12, 2026

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Gamified test

child carries a Radio-frequency identification (RFID) tag to scan at each lap, watching avatar level up.

active comparator: Standard test

no game; same verbal cue every minute

Interventions

Standard 6MWT

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 6MWT

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.

Primary outcome measure

  • Change in 6 minute walk distance [ Time Frame: Baseline and post intervention (approximately 20 minutes) ]

Central Contacts and Locations

Central contacts

David N Toupin, MD

859-218-1900d.n.toupin@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

David N Toupin, MD

859-218-1900d.n.toupin@uky.edu

More Information

Sponsor

David Toupin

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • Gamification
  • Walk Test

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by David Toupin on 2026-07-27.