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Cerebral PalsyNEFES-CPNCT07681947

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

A study testing N.E.F.E.S.-CP Education Model in people with Cerebral Palsy, run by Yeditepe University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Cerebral Palsy
What is being tested?
N.E.F.E.S.-CP Education Model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Jul 2026to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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).

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Spastic Children's Foundation of Turkey (TSÇV)

    Istanbul, İ̇stanbul, 34755

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the detailed description

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.

Conditions
Cerebral Palsy
Being tested
N.E.F.E.S.-CP Education Model
Keywords
awareness, cerebral palsy, gamification, posture, respiration
Medical subject headings
Cerebral Palsy, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • N.E.F.E.S.-CP Education ModelBehavioural

    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.

Study groups in NCT07681947
Study groupRoleWhat they receive
Experimental GroupExperimentalAll 40 children with cerebral palsy aged 6-18 years included in the study will receive the N.E.F.E.S.-CP gamified breathing and postural awareness education model. The training program will be conducted twice a week for 8 weeks at the Spastic Children's Foundation of Turkey (TSÇV).
Receives: Behavioral: N.E.F.E.S.-CP Education Model

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 8 weeks (from baseline to post-intervention)

Secondary outcomes (3)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 8 weeks (from baseline to post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2026
  2. Study start10 Jul 2026 (estimated)
  3. Primary completion27 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07681947
Sponsor's protocol ID
yeditepe03
Acronym
NEFES-CP
Status last verified
Jul 2026
First submitted
24 Jun 2026
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared to protect the privacy and confidentiality of the participants, particularly children with cerebral palsy. The data collected will be used strictly for the purposes of this scientific study and will be stored securely by the research team in accordance with ethical guidelines and institutional policies.

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 11002433
  • Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.

    PubMed 9183258
  • Cemali O, Tiryaki AY, Cemali M, Torpil B. Effects of feeding behavior training on sensory processing and developmental areas in children with cerebral visual impairment: a randomized controlled study. Ital J Pediatr. 2026 Feb 14;52(1):42. doi: 10.1186/s13052-026-02213-w.

    PubMed 41691324
  • Palmer KN, Kelman GR. Pulmonary function in asthmatic patients in remission. Br Med J. 1975 Mar 1;1(5956):485-6. doi: 10.1136/bmj.1.5956.485.

    PubMed 236066
  • Keles MN, Elbasan B, Apaydin U, Aribas Z, Bakirtas A, Kokturk N. Effects of inspiratory muscle training in children with cerebral palsy: a randomized controlled trial. Braz J Phys Ther. 2018 Nov-Dec;22(6):493-501. doi: 10.1016/j.bjpt.2018.03.010. Epub 2018 Apr 4.

    PubMed 29636305
  • de Lima Crispim TR, Neto MG, Crispim TRL, Dias RB, de Albuquerque MDM, Saquetto MB, Magalhaes PAF. Addition of respiratory exercises to conventional rehabilitation for children and adolescents with cerebral palsy: a systematic review and meta-analysis. World J Pediatr. 2023 Apr;19(4):340-355. doi: 10.1007/s12519-022-00642-1. Epub 2022 Nov 15.

    PubMed 36376558
  • Debouche S, Pitance L, Robert A, Liistro G, Reychler G. Reliability and Reproducibility of Chest Wall Expansion Measurement in Young Healthy Adults. J Manipulative Physiol Ther. 2016 Jul-Aug;39(6):443-449. doi: 10.1016/j.jmpt.2016.05.004. Epub 2016 Jun 23.

    PubMed 27346860
  • American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.

    PubMed 12186831

Questions about this trial

What is this clinical trial studying?

A study testing N.E.F.E.S.-CP Education Model in people with Cerebral Palsy, run by Yeditepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rasmi Muammer, Prof., PhD (+90 505 650 28 27, rasmi.muammer@yeditepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spirometry Assessment FVC (time frame: 8 weeks (from baseline to post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07681947, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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