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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorYeditepe University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Experimental GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Spirometry Assessment FVC

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.

Time frame
8 weeks (from baseline to post-intervention)
2

Spirometry Assessment FEV1

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.

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

Secondary outcomes

1

Postural assessment

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.

Time frame
8 weeks (from baseline to post-intervention)
2

Quality of Life (CPQOL-Child)

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.

Time frame
8 weeks (from baseline to post-intervention)
3

Thoracic Mobility Assessment

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.

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

Other outcomes

Sponsors and contacts

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Yeditepe University

Lead sponsor

Fenerbahce University

Collaborator

Istanbul University - Cerrahpasa

Collaborator

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