Expiratory Muscle Training in Children With Cerebral Palsy

NCT07048223 | Not Yet Recruiting

• 1 other identifier: IstinyeUni-Z.KAVRIK.001
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to examine the effects of expiratory muscle training on posture, trunk control, balance, selective motor control, and respiratory function in children with spastic-type cerebral palsy (CP). The research focuses on evaluating an innovative rehabilitation approach that addresses common challenges observed in children with CP, such as trunk instability, reduced respiratory capacity, and postural abnormalities. In individuals with CP, the ineffective use of respiratory muscles affects not only the respiratory system but also trunk control and overall motor performance. While most existing studies emphasize inspiratory muscle training, research on expiratory muscle training remains limited. Therefore, this study seeks to fill this gap by investigating the neuromotor effects of expiratory muscle training-an emerging component of respiratory rehabilitation-in children with CP.

Conditions

Cerebral Palsy (CP)

Keywords

cerebral palsy; expiratory muscle training; trunk control; posture; balance; respiratory rehabilitation

Outcome Measures

Primary Outcomes (6)

• Respiratory Muscle Strength Assessment (MIP/MEP)

  Before treatment, week 8

• Peak Cough Flow

  before treatment, week 8

• Assessment of Posture (PostureScreen App)

  before treatment, week 8

• Trunk Control Assessment (ProKin Star Excursion Balance Test, Trunk Control Measurement Scale (TCMS))

  Trunk control will be assessed using the Trunk Control Measurement Scale (TCMS) and the ProKin Star Excursion Balance Test. The TCMS evaluates static and dynamic trunk control in children with cerebral palsy. Scores range from 0 to 58, with higher scores indicating better trunk control. The ProKin Star Excursion Balance Test measures postural stability and trunk coordination using a computerized force platform. Assessments will be conducted before treatment and at the end of the 8th week.

  Before treatment, week 8

• Balance Assessment (PROKIN®)

  before treatmant, week 8

• Selective Motor Control Assessment (SCALE), (Noraxon MyoMotion)

  Selective motor control will be assessed using the Selective Control Assessment of the Lower Extremity (SCALE). The SCALE evaluates the ability to perform isolated joint movements in the lower limbs and is scored bilaterally. Each limb can score from 0 to 10 points, with a total possible score ranging from 0 to 20. Higher scores indicate better selective voluntary motor control. Additionally, Noraxon MyoMotion will be used to collect objective kinematic data to support the SCALE assessment.

  before treatment, week 8

Secondary Outcomes (6)

• Communication Function Classification System (CFCS)

  before treatment

• Gross Motor Function Classification System (GMFCS)

  before treatment

• Muscle Tone Evaluation (Modified Ashworth Scale (MAS))

  before treatment

• Gross Motor Function Measure (GMFM)

  before treatment, week 8

• Modified Functional Reach Test (MFRT)

  before treatment, week 8

Study Arms (2)

Expiratory Muscle Training

EXPERIMENTAL

In this group, expiratory muscle training will be administered using the POWERbreathe EX1 device, set at 50% of each participant's measured maximal expiratory pressure (MEP). Participants will be instructed to perform the exercises daily at home for a duration of 8 weeks. Interim assessments will be conducted every 10 days. Exercise compliance will be monitored using daily exercise tracking forms.

Behavioral: Expiratory Muscle Training

Sham Expiratory Muscle Training

SHAM COMPARATOR

In the sham expiratory muscle training group, participants will perform a respiratory exercise program including breathing control, diaphragmatic breathing, and thoracic expansion exercises. In addition, sham expiratory muscle training will be administered using the POWERbreathe EX1 device set at 10% of the participant's measured maximal expiratory pressure (MEP), providing minimal resistance. Participants will be instructed to perform the exercises daily at home for a period of 8 weeks. Compliance will be monitored through exercise tracking forms. No progressive loading or resistance adjustments will be made during the intervention period.

Behavioral: Sham Expiratory Muscle Training

Interventions

Expiratory Muscle Training BEHAVIORAL

In the expiratory muscle training group, participants will receive a respiratory exercise program consisting of breathing control, diaphragmatic breathing, and thoracic expansion exercises. In addition, expiratory muscle training (EMT) will be performed using the POWERbreathe EX1 device at 50% of each participant's measured maximal expiratory pressure (MEP). Participants will be instructed to perform 25 repetitions per session, structured as 5 cycles of 5 breaths with 1-minute rest intervals between each cycle. The training will be performed daily at home for a duration of 8 weeks. Compliance will be monitored through exercise tracking forms. To ensure progressive loading, MEP will be reassessed every 10 days, and the resistance of the device will be adjusted accordingly. Participants will be invited for in-person interim evaluations at these 10-day intervals to update their training parameters.

Expiratory Muscle Training

Sham Expiratory Muscle Training BEHAVIORAL

In the sham expiratory muscle training group, participants will perform a respiratory exercise program including breathing control, diaphragmatic breathing, and thoracic expansion exercises. In addition, sham expiratory muscle training will be administered using the POWERbreathe EX1 device set at 10% of the participant's measured maximal expiratory pressure (MEP), providing minimal resistance. Participants will be instructed to perform the exercises daily at home for a period of 8 weeks. Compliance will be monitored through exercise tracking forms. No progressive loading or resistance adjustments will be made during the intervention period.

Sham Expiratory Muscle Training

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of cerebral palsy
• Age between 12 and 18 years
• Gross Motor Function Classification System (GMFCS) Level I or II
• Communication Function Classification System (CFCS) Level I, II, or III
• Spasticity graded as 0, 1, 1+, or 2 on the Modified Ashworth Scale
• No history of Botulinum Toxin-A injection or orthopedic surgery within the past 6 months

You may not qualify if:

• Spasticity graded as 3 or 4 on the Modified Ashworth Scale Uncontrolled seizures
• Presence of congenital cardiopulmonary disease, autism spectrum disorder, balance-impairing conditions, or significant visual/hearing impairments
• Acute respiratory tract infection

Sponsors & Collaborators

• Istinye University: lead

Related Publications (3)

• 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: 36376558 BACKGROUND

• Menezes KKP, Avelino PR, Alvarenga MTM, Nascimento LR. Inspiratory Training for Improving Respiratory Strength, Pulmonary Function, and Walking in Cerebral Palsy: A Meta-Analysis. Pediatr Phys Ther. 2024 Apr 1;36(2):207-215. doi: 10.1097/PEP.0000000000001092. Epub 2024 Mar 29.

  PMID: 38568267 BACKGROUND

• Ishida H, Suehiro T, Watanabe S. Comparison of abdominal muscle activity and peak expiratory flow between forced vital capacity and fast expiration exercise. J Phys Ther Sci. 2017 Apr;29(4):563-566. doi: 10.1589/jpts.29.563. Epub 2017 Apr 20.

  PMID: 28533585 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Dilek ÇOKAR

  Istinye University

  STUDY CHAIR

Central Study Contacts

Zeynep KAVRIK

CONTACT

+905076884614; zeynepsavas35@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This randomized controlled trial consists of two parallel groups and is designed to compare the effects of expiratory muscle training with those of sham expiratory muscle training in children with spastic-type cerebral palsy.

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: July 30, 2025
• Primary Completion: January 30, 2026
• Study Completion: March 30, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Summary-level data and supporting documents (e.g., study protocol and statistical analysis plan) will be available within 12 months following the final publication of study results and will remain accessible for at least 5 years via institutional repository or upon reasonable request.
• Access Criteria: The study's outcome results, including group-level means, standard deviations, p-values, and effect sizes, as well as supporting materials such as the study protocol and statistical analysis plan, will be made available to qualified academic researchers upon reasonable request. Data will be provided for ethically approved, non-commercial research purposes. Interested investigators should contact the principal investigator through the affiliated institution and submit a written request describing the intended use and data handling procedures. Each request will be reviewed individually in accordance with institutional data-sharing guideline.