NCT07216339

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Apr 2026Dec 2026

First Submitted

Initial submission to the registry

October 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

October 10, 2025

Last Update Submit

March 6, 2026

Conditions

Keywords

GamificationWalk Test

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline and post intervention (approximately 20 minutes)

Secondary Outcomes (4)

  • Change in Children's OMNI Rate of Perceived Exertion (RPE) Scale

    Baseline and post intervention (approximately 20 minutes)

  • Change in Physical Activity Enjoyment Scale (PACES)

    Baseline and post intervention (approximately 20 minutes)

  • Recruitment Rate

    9 months

  • Test completion rate

    9 months

Study Arms (2)

Gamified test

EXPERIMENTAL

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

Other: Gamified 6MWT

Standard test

ACTIVE COMPARATOR

no game; same verbal cue every minute

Other: Standard 6MWT

Interventions

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.

Standard test

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.

Gamified test

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Study Officials

  • David N Toupin, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David N Toupin, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 10, 2025

First Posted

October 14, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations