跳至主要内容
临床试验/NCT07681947
NCT07681947尚未招募不适用

N.E.F.E.S.-CP (Qualified Education for Awareness, Accessible Breathing: Cerebral Palsy) A Gamified Breathing and Postural Awareness Education Model

Yeditepe University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Spirometry Assessment FVC

研究概览

简要总结

This project aims to develop an accessible, learning-oriented model based on gamified breathing and posture training that emphasizes active participation for children with cerebral palsy (CP), their families, and educators. Since current practices are largely clinic-centered, there is a growing need for game-based, motivational and widely discernible programs. In this context, the project aims to provide an inclusive model that enhances breathing and postural awareness through digital technology, thereby increasing motivation and adherence.

详细描述

Within the scope of the project, gamified hands-on workshops including breathing exercises and postural imagery techniques supported by visual and auditory stimuli, such as candle blowing, boat floating, and triflo simulations, will be conducted twice a week for eight weeks at the Spastic Children's Foundation of Turkey (TSÇV) with the guidance of an instructor. Additionally, educational digital games and storytelling videos will be developed to support home-based programs participation.

An initial awareness education session will be held to provide children with CP, families, and educators with foundational knowledge on breathing and postural awareness in children with CP. Throughout the project, gamified videos will be shared on the project's website to reach a wider population. Furthermore, a workshop for educators and a closing seminar for families will be organized.

The target groups include children with CP, their families, and educators involved in educational processes. 40 children with CP aged 6-18 years, receiving rehabilitation at TSÇV, with literacy skills and parental consent, will participate. The effects of the N.E.F.E.S.-CP model to be developed on respiratory functions, body awareness, posture, social participation, and quality of life will be evaluated using standardized assessment methods.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with cerebral palsy.
  • Classified as Level I-III according to the Gross Motor Function Classification System (GMFCS).
  • Aged between 6 and 18 years.
  • Having a cognitive level sufficient to understand and follow simple instructions (for active participation in gamified training).

排除标准

  • Presence of uncontrolled medical conditions or systemic limitations.
  • Use of medications affecting respiratory function.
  • Presence of musculoskeletal problems (other than CP diagnosis) that may affect walking ability, and/or the presence of cognitive and mental impairment that may affect participation and/or motivation.
  • Visual or hearing loss that severely restricts participation in digital game and video-based applications (if appropriate adaptation cannot be provided).

结局指标

主要结局

Spirometry Assessment FVC

时间窗: 8 weeks (from baseline to post-intervention)

Spirometric variables will be measured using a calibrated spirometer (Medical International Research Spirodoc®) to evaluate respiratory function. Participants will be instructed to perform maximal inhalation followed by a forceful and complete exhalation into the spirometer in accordance with standardized spirometry guidelines. To minimize measurement error and ensure accuracy, three valid trials will be performed, and the highest recorded values will be used for final analysis. Spirometry is a well-established, reliable, and objective method for assessing pulmonary function in clinical settings.

Spirometry Assessment FEV1

时间窗: 8 weeks (from baseline to post-intervention)

Spirometric variables will be measured using a calibrated spirometer (Medical International Research Spirodoc®) to evaluate respiratory function. Participants will be instructed to perform maximal inhalation followed by a forceful and complete exhalation into the spirometer in accordance with standardized spirometry guidelines. To minimize measurement error and ensure accuracy, three valid trials will be performed, and the highest recorded values will be used for final analysis. Spirometry is a well-established, reliable, and objective method for assessing pulmonary function in clinical settings.

次要结局

  • Postural assessment(8 weeks (from baseline to post-intervention))
  • Quality of Life (CPQOL-Child)(8 weeks (from baseline to post-intervention))
  • Thoracic Mobility Assessment(8 weeks (from baseline to post-intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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