Recruiting NCT07216339
Gamification Effects on the 6-Minute Walk Test in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard 6MWT, Gamified 6MWT.
- Who it may be relevant to
- Registry conditions: Neuromuscular Diseases in Children. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Gamification on 6-Minute Walk Test Performance and Engagement in Pediatric Neuromuscular Patients
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Change in 6 minute walk distance [Time frame: Baseline and post intervention (approximately 20 minutes)]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Kentucky — Lexington
Identifiers
NCT: NCT07216339 · 103847