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Набор скоро начнётся NCT07681947

A Gamified Breathing and Postural Awareness Education Model for Children With Cerebral Palsy

Без фазы С лечением Cerebral Palsy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: N.E.F.E.S.-CP Education Model.
Кому может быть актуально
Состояния в реестре: Cerebral Palsy. Базовые параметры: 6 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое N.E.F.E.S.-CP Education Model
    Gamified breathing and postural awareness training, including hands-on workshops with exercises such as candle blowing, boat floating, and triflo simulations, alongside postural imagery techniques supported by visual and auditory stimuli. The program will be conducted twice a week for 8 weeks.

Первичные конечные точки

  • Spirometry Assessment FVC [Срок оценки: 8 weeks (from baseline to post-intervention)]
  • Spirometry Assessment FEV1 [Срок оценки: 8 weeks (from baseline to post-intervention)]
Вторичные конечные точки (3)
  • Postural assessment [Срок оценки: 8 weeks (from baseline to post-intervention)]
  • Quality of Life (CPQOL-Child) [Срок оценки: 8 weeks (from baseline to post-intervention)]
  • Thoracic Mobility Assessment [Срок оценки: 8 weeks (from baseline to post-intervention)]

Критерии участия

Критерии включения

  • 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).

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Spastic Children's Foundation of Turkey (TSÇV) — Istanbul

Публикации

  • Winther L, Milther C, Schroll SM, Nielsen ET, Gjaerde LK, Curtis DJ, Sorensen JL, Stahlhut M. Digital play and rehabilitation for children and adolescents in hospitals, outpatient departments and rehabilitation centres: A scoping review. J Pediatr Rehabil Med. 2025 Aug;18(3):177-188. doi: 10.1177/18758894251341153. Epub 2025 Jun 13. PMID 40509926
  • Waters E, Davis E, Mackinnon A, Boyd R, Graham HK, Kai Lo S, Wolfe R, Stevenson R, Bjornson K, Blair E, Hoare P, Ravens-Sieberer U, Reddihough D. Psychometric properties of the quality of life questionnaire for children with CP. Dev Med Child Neurol. 2007 Jan;49(1):49-55. doi: 10.1017/s0012162207000126.x. PMID 17209977
  • Waters E, Maher E, Salmon L, Reddihough D, Boyd R. Development of a condition-specific measure of quality of life for children with cerebral palsy: empirical thematic data reported by parents and children. Child Care Health Dev. 2005 Mar;31(2):127-35. doi: 10.1111/j.1365-2214.2004.00476.x. PMID 15715691
  • Tas SA, Cankaya T. Effects of structured training on spinal posture and selective motor control in children with unilateral spastic cerebral palsy. Gait Posture. 2024 Mar;109:22-27. doi: 10.1016/j.gaitpost.2024.01.007. Epub 2024 Jan 11. PMID 38244393
  • Szturm T, Parmar ST, Mehta K, Shetty DR, Kanitkar A, Eskicioglu R, Gaonkar N. Game-Based Dual-Task Exercise Program for Children with Cerebral Palsy: Blending Balance, Visuomotor and Cognitive Training: Feasibility Randomized Control Trial. Sensors (Basel). 2022 Jan 19;22(3):761. doi: 10.3390/s22030761. PMID 35161508
  • 10.16965/ijpr.2016.197
  • S R, Kanniappan V, Santhosh Kanna BS, T S V. Comparing the Effects of Virtual Reality Breathing Exercise and Incentive Spirometry Exercise on Improving Pulmonary Function in Children with Spastic Diplegic Cerebral Palsy. Cureus. 2024 Apr 27;16(4):e59149. doi: 10.7759/cureus.59149. eCollection 2024 Apr. PMID 38803793
  • Palisano RJ, Hanna SE, Rosenbaum PL, Russell DJ, Walter SD, Wood EP, Raina PS, Galuppi BE. Validation of a model of gross motor function for children with cerebral palsy. Phys Ther. 2000 Oct;80(10):974-85. PMID 11002433

Идентификаторы

NCT: NCT07681947 · yeditepe03

Первоисточники (государственные реестры)

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