Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 6 Years and 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Gamified test 		child carries a Radio-frequency identification (RFID) tag to scan at each lap, watching avatar level up.
  • Other: 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.
Active Comparator
Standard test 		no game; same verbal cue every minute
  • Other: 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.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington 4297983, Kentucky 6254925 40506
Contact:
David N Toupin, MD
859-257-1900
d.n.toupin@uky.edu

More Details

NCT ID
NCT07216339
Status
Recruiting
Sponsor
David Toupin

Study Contact

David N Toupin, MD
859-257-1900
d.n.toupin@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.