NCT07681947

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jul 2026Nov 2026

First Submitted

Initial submission to the registry

June 24, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

July 10, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2026

Expected
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

July 2, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

June 24, 2026

Last Update Submit

July 1, 2026

Conditions

Keywords

awarenesscerebral palsygamificationposturerespiration

Outcome Measures

Primary Outcomes (2)

  • 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.

    8 weeks (from baseline to post-intervention)

  • 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.

    8 weeks (from baseline to post-intervention)

Secondary Outcomes (3)

  • 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)

Study Arms (1)

Experimental Group

EXPERIMENTAL

All 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).

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

Interventions

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.

Experimental Group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spastic Children's Foundation of Turkey (TSÇV)

Istanbul, İ̇stanbul, 34755, Turkey (Türkiye)

Location

Related Publications (15)

  • 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: 40509926BACKGROUND
  • 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: 17209977BACKGROUND
  • 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: 15715691BACKGROUND
  • 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: 38244393BACKGROUND
  • 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: 35161508BACKGROUND
  • 10.16965/ijpr.2016.197

    BACKGROUND
  • 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: 38803793BACKGROUND
  • 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: 11002433BACKGROUND
  • 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.

    PMID: 9183258BACKGROUND
  • 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.

    PMID: 41691324BACKGROUND
  • 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.

    PMID: 236066BACKGROUND
  • 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.

    PMID: 29636305BACKGROUND
  • 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.

    PMID: 36376558BACKGROUND
  • 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.

    PMID: 27346860BACKGROUND
  • 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.

    PMID: 12186831BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyRespiratory Aspiration

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2026

First Posted

July 2, 2026

Study Start

July 10, 2026

Primary Completion (Estimated)

November 27, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

July 2, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations