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NCT Number: NCT07048223

Expiratory Muscle Training in Children With Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Respiratory Muscle Strength Assessment (MIP/MEP)

    Time frame: Before treatment, week 8

  2. Peak Cough Flow

    Time frame: before treatment, week 8

  3. Assessment of Posture (PostureScreen App)

    Time frame: before treatment, week 8

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

    Time frame: Before treatment, week 8

    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.

  5. Balance Assessment (PROKIN®)

    Time frame: before treatmant, week 8

  6. Selective Motor Control Assessment (SCALE), (Noraxon MyoMotion)

    Time frame: before treatment, week 8

    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.

Secondary outcomes

  1. Communication Function Classification System (CFCS)

    Time frame: before treatment

    The Communication Function Classification System (CFCS) is a five-level classification system used to describe everyday communication performance in individuals with cerebral palsy. Levels range from I (most effective communicator) to V (least effective communicator). Lower levels indicate more effective and independent communication abilities.

  2. Gross Motor Function Classification System (GMFCS)

    Time frame: before treatment

    The Gross Motor Function Classification System (GMFCS) is a five-level system used to classify gross motor function in children with cerebral palsy. Levels range from I (most independent) to V (most limited). Lower levels represent better motor function and greater independence in mobility.

  3. Muscle Tone Evaluation (Modified Ashworth Scale (MAS))

    Time frame: before treatment

    Muscle tone will be assessed using the Modified Ashworth Scale (MAS), a widely used clinical tool for measuring spasticity. The scale ranges from 0 to 4, with an additional score of 1+ to indicate slight increases in muscle tone. A score of 0 indicates no increase in muscle tone, while a score of 4 indicates a rigid limb in flexion or extension. Higher scores reflect greater spasticity.

  4. Gross Motor Function Measure (GMFM)

    Time frame: before treatment, week 8

    Gross motor function will be evaluated using selected sections of the Gross Motor Function Measure (GMFM-88), a standardized observational tool developed to assess changes in motor function in children with cerebral palsy. In this study, only dimensions D (Standing) and E (Walking, Running, and Jumping) will be administered. Each item is scored on a 4-point ordinal scale from 0 (does not initiate) to 3 (completes the activity). Scores will be expressed as a percentage of the maximum possible score for the selected dimensions, with higher percentages indicating better gross motor performance.

  5. Modified Functional Reach Test (MFRT)

    Time frame: before treatment, week 8

    Dynamic balance will be assessed using the Modified Functional Reach Test (MFRT), which evaluates the maximum distance an individual can reach forward and laterally while maintaining a fixed base of support in a seated position. The test is performed in three directions: forward, right, and left. The distance is measured in centimeters. Higher reach distances indicate better dynamic sitting balance and trunk stability.

  6. Prone Plank Test

    Time frame: before treatment, week 8

    Core endurance will be assessed using the Prone Plank Test, which measures the amount of time an individual can maintain a prone plank position (forearms and toes supporting the body, body in a straight line) without losing form. The test is performed on a flat surface, and time is recorded in seconds. A longer duration indicates greater core muscle endurance.

Study contacts

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

Zeynep KAVRIK

CONTACT

[email protected]

+905076884614

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

Effects of Expiratory Muscle Training on Posture, Balance, Trunk Control, and Respiratory Function in Children With Cerebral Palsy

Acronym: CP-EMT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2025
Registry last updated
Jul 22, 2025

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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