Cerebral Palsy (CP)CP-EMTNCT07048223
Expiratory Muscle Training in Children With Cerebral Palsy
A study testing Expiratory Muscle Training in people with Cerebral Palsy (CP), run by Istinye University.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Expiratory Muscle Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2025to 30 Mar 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Expiratory Muscle Training on Posture, Balance, Trunk Control, and Respiratory Function 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.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Expiratory Muscle Training, Sham Expiratory Muscle Training
- Keywords
- cerebral palsy, expiratory muscle training, trunk control, posture, balance, respiratory rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiratory Muscle TrainingBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sham Expiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Muscle Strength Assessment (MIP/MEP)
Measured: Before treatment, week 8
Peak Cough Flow
Measured: before treatment, week 8
Assessment of Posture (PostureScreen App)
Measured: 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.
Measured: Before treatment, week 8
Balance Assessment (PROKIN®)
Measured: 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.
Measured: before treatment, week 8
Secondary outcomes (6)
Communication Function Classification System (CFCS)
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.
Measured: before treatment
Gross Motor Function Classification System (GMFCS)
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.
Measured: before treatment
Muscle Tone Evaluation (Modified Ashworth Scale (MAS))
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.
Measured: before treatment
Gross Motor Function Measure (GMFM)
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.
Measured: before treatment, week 8
Modified Functional Reach Test (MFRT)
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.
Measured: before treatment, week 8
Prone Plank Test
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.
Measured: before treatment, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start30 Jul 2025 (estimated)
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dilek ÇOKAR, Study chair, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048223
- Sponsor's protocol ID
- IstinyeUni-Z.KAVRIK.001
- Acronym
- CP-EMT
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will share de-identified, summary-level outcome data, including group-level means, standard deviations, effect sizes, and p-values derived from statistical analyses. These data will be provided to support transparency and allow for interpretation of the study findings.
Publications
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 36376558Menezes 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.
PubMed 38568267Ishida 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.
PubMed 28533585
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Expiratory Muscle Training on Posture, Balance, Trunk Control, and Respiratory Function in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07048223
- Acronym / sponsor ID
- CP-EMT / IstinyeUni-Z.KAVRIK.001
- Conditions
- Cerebral Palsy (CP)
- Keywords
- cerebral palsy, expiratory muscle training, trunk control, posture, balance, respiratory rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Expiratory Muscle Training | Experimental | Behavioral: Expiratory Muscle TrainingIn 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. |
| Sham Expiratory Muscle Training | Sham comparator | Behavioral: Sham Expiratory Muscle TrainingIn 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expiratory Muscle TrainingIn 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. | Behavioural | Expiratory Muscle Training |
| Sham Expiratory Muscle TrainingIn 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. | Behavioural | Sham Expiratory Muscle Training |
Primary outcome
Respiratory Muscle Strength Assessment (MIP/MEP)
Time frame: Before treatment, week 8
Peak Cough Flow
Time frame: before treatment, week 8
Assessment of Posture (PostureScreen App)
Time frame: before treatment, week 8
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.
Balance Assessment (PROKIN®)
Time frame: before treatmant, week 8
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.
6 secondary outcomes
Communication Function Classification System (CFCS)
Time frame: before treatment
Gross Motor Function Classification System (GMFCS)
Time frame: before treatment
Muscle Tone Evaluation (Modified Ashworth Scale (MAS))
Time frame: before treatment
Gross Motor Function Measure (GMFM)
Time frame: before treatment, week 8
Modified Functional Reach Test (MFRT)
Time frame: before treatment, week 8
Prone Plank Test
Time frame: before treatment, week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Background: PubMed 36376558de 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.
- Background: PubMed 38568267Menezes 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.
- Background: PubMed 28533585Ishida 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.
- Individual participant dataSharing planned: Yes. The study will share de-identified, summary-level outcome data, including group-level means, standard deviations, effect sizes, and p-values derived from statistical analyses. These data will be provided to support transparency and allow for interpretation of the study findings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dilek ÇOKAR study chair
Istinye University
Questions about this trial
What is this clinical trial studying?
A study testing Expiratory Muscle Training in people with Cerebral Palsy (CP), run by Istinye University.
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 6 inclusion and 3 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 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Zeynep KAVRIK (+905076884614, zeynepsavas35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Muscle Strength Assessment (MIP/MEP) (time frame: Before treatment, week 8). The study lists 6 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 NCT07048223, which also lists 3 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 22 Jul 2025.