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临床试验/NCT07216339
NCT07216339招募中不适用

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

David Toupin2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年6月12日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
2
主要终点
Change in 6 minute walk distance

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Gamified test

Experimental

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

干预措施: Gamified 6MWT (Other)

Standard test

Active Comparator

no game; same verbal cue every minute

干预措施: Standard 6MWT (Other)

结局指标

主要结局

Change in 6 minute walk distance

时间窗: 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

次要结局

  • Recruitment Rate(9 months)
  • Test completion rate(9 months)
  • 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)

研究者

发起方
David Toupin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David Toupin

Assistant Professor

University of Kentucky

研究点 (2)

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