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NCT Number: NCT07216339

Gamification Effects on the 6-Minute Walk Test in Children

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.

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Key information

Conditions

Neuromuscular Diseases in Children

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location status: Recruiting

Location contact

David N Toupin, MD

CONTACT

[email protected]

859-218-1900

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard 6MWT

Other

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

Other

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 outcomes

  1. 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

Secondary outcomes

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

    Time frame: Baseline and post intervention (approximately 20 minutes)

    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.

  2. Change in Physical Activity Enjoyment Scale (PACES)

    Time frame: Baseline and post intervention (approximately 20 minutes)

    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.

  3. Recruitment Rate

    Time frame: 9 months

    percent of eligible participants successfully recruited in the study

  4. Test completion rate

    Time frame: 9 months

    number of walk tests successfully completed compared to overall number of walk tests

Study contacts

Contact information is provided by the study sponsor or research team.

David N Toupin, MD

CONTACT

[email protected]

859-218-1900

Sponsors and collaborators

Lead sponsor

David Toupin

Other

Registry information

Official study title

Effect of Gamification on 6-Minute Walk Test Performance and Engagement in Pediatric Neuromuscular Patients

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 14, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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