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NCT Number: NCT07681947

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spastic Children's Foundation of Turkey (TSÇV)

Istanbul, İ̇stanbul, 34755, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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).

Exclusion criteria

  • 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).

Treatment and study plan

N.E.F.E.S.-CP Education Model

Behavioral

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.

Primary outcomes

  1. Spirometry Assessment FVC

    Time frame: 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.

  2. Spirometry Assessment FEV1

    Time frame: 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.

Secondary outcomes

  1. Postural assessment

    Time frame: 8 weeks (from baseline to post-intervention)

    Posture will be evaluated using the New York Posture Rating Test. This assessment method divides the body into distinct regions according to anatomical alignment, allowing for a comprehensive evaluation of posture in the sagittal and frontal planes. Each body region is scored based on standardized criteria, and the total score provides an objective measure of postural alignment.

  2. Quality of Life (CPQOL-Child)

    Time frame: 8 weeks (from baseline to post-intervention)

    Quality of life will be assessed using the Cerebral Palsy Quality of Life Questionnaire (CPQOL-Child). This condition-specific measure is designed to capture the unique perspectives and experiences of children with cerebral palsy, covering various domains such as physical well-being, social participation, and emotional functioning.

  3. Thoracic Mobility Assessment

    Time frame: 8 weeks (from baseline to post-intervention)

    Thoracic mobility will be assessed through chest circumference measurements to determine thoracic expansion capacity. To ensure the reliability and clinical accuracy of the data, measurements will be taken at three standardized anatomical levels: the axillary, the nipple/xiphoid process, and the sub-xiphoid levels. Participants will be instructed to perform maximal inspiration and maximal expiration while in a seated position. All measurements will be recorded using a tape measure. To control for measurement error, each measurement will be repeated three times, and the mean value will be used for final analysis. Thoracic expansion will be calculated as the quantitative difference between the chest circumference values obtained during maximal inspiration and maximal expiration. This measurement technique is recognized as a reliable and clinically feasible approach for evaluating thoracic mobility in pediatric populations.

Study contacts

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

Rasmi Muammer, Prof., PhD

CONTACT

[email protected]

+90 505 650 28 27

Turgay Arik

CONTACT

[email protected]

0542 646 5394

Sponsors and collaborators

Lead sponsor

Yeditepe University

Other

Collaborators

  • Fenerbahce University
  • Istanbul University - Cerrahpasa

Registry information

Official study title

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

Acronym: NEFES-CP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2026
Registry last updated
Jul 2, 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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