Cerebral Palsy Spastic DiplegiaNCT05559346
Investigation of the Effects of Diaphragm Exercises in Children With Cerebral Palsy
A study testing Diaphragmatic exercises and conventional physiotherapy in people with Cerebral Palsy Spastic Diplegia, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effects of diaphragmatic myofascial relaxation exercise and diaphragmatic breathing exercises added to the conventional physiotherapy and rehabilitation program in children with diplegic cerebral palsy (CP), primarily on MIP, MEP, and secondarily on thoracic cage mobility… Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Cerebral Palsy Spastic Diplegia
- What is being tested?
- Diaphragmatic exercises and conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 2 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being diagnosed with spastic diplegic cerebral palsy
- Being between the ages of 5-15
- Gross Motor Functional Classification System 1,2 or 3
- To be at a cognitive level to be able to understand and apply the instructions in the tests (SFT, MIP, MEP) to be applied
Who cannot join
- Having had a surgical operation in the last 6 months
- Presence of scoliosis detected above 30 degrees
- Having a planned surgery within 3 months from the start of the study
- Have a chronic lung disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Training and Research Hospital
Istanbul, 34890
About this study
The aim of this study is to examine the effects of diaphragmatic myofascial relaxation exercise and diaphragmatic breathing exercises added to the conventional physiotherapy and rehabilitation program in children with diplegic cerebral palsy (CP), primarily on MIP, MEP, and secondarily on thoracic cage mobility, pulmonary functions and sitting ability.
Read the detailed description
This research is a randomized controlled trial. Volunteers diagnosed with cerebral palsy who applied to Marmara University Pendik Training and Research Hospital will participate in the research. A voluntary consent form will be obtained from the participants at the beginning of the study. Demographic and clinical information form will be filled for each patient at the beginning of the study before clinical evaluations. Demographic and clinical information form; Age, gender, height, weight, body mass index (BMI), how many weeks were born, birth weight, drug use, disease history, number of siblings, neonatal intensive care hospitalization history, education level of parents will be questioned. The Gross Motor Functional Classification System (KMFSS) will be used to determine the functionality levels of the volunteers who will participate in the study. The following tests will be applied to all of the volunteers who will participate in our study before and after the intervention:
Respiratory Muscle Strength Measurement Thoracic Cage Mobility Assessment Pulmonary Function Tests Gross Motor Functional Measurement (part B) Children meeting the inclusion criteria will be randomly assigned to two groups. The control and research groups will receive an individualized conventional rehabilitation program for 45 minutes, 2 days a week for 8 weeks. In addition to conventional rehabilitation, manual diaphragmatic relaxation exercises and diaphragmatic breathing exercises will be applied to the children in the research group two days a week.
After 8 weeks of intervention and control group applications, the evaluations made at the beginning of the intervention will be repeated. The evaluations of the two groups will be compared statistically and the results will be interpreted.
- Conditions
- Cerebral Palsy Spastic Diplegia
- Being tested
- Diaphragmatic exercises, conventional physiotherapy
- Keywords
- cerebral palsy, respiratory strength, pulmonary functions, sitting ability
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic exercisesOther
Diaphragm exercises will be applied to the research group in addition to conventional rehabilitation.The content of the individualized conventional rehabilitation program consists of passive stretching exercises, strengthening exercises to antagonists of spastic muscles and exercises aimed at improving weight transfer, balance and correction reactions, and postural control. In addition to conventional rehabilitation, manual diaphragmatic relaxation exercises and diaphragmatic breathing exercises will be applied to the children in the research group two days a week.
conventional physiotherapyOther
The control group will only be taken to the conventional rehabilitation program. e content of the individualized conventional rehabilitation program consists of passive stretching exercises, strengthening exercises to antagonists of spastic muscles and exercises aimed at improving weight transfer, balance and correction reactions, and postural control.
| Study group | Role | What they receive |
|---|---|---|
| Research Group | Experimental | Diplegic Cerebral Palsy Receives: Other: Diaphragmatic exercises |
| Control Group | Active comparator | Diplegic Cerebral Palsy Receives: Other: conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Muscle Strength Measurement (Maximum inspiratory pressure)
It will be used as the primary outcome measure in the study. In our study, respiratory muscle strength will be measured with a portable intraoral pressure measuring device (MicroRPM) Maximum static inspiratory pressure (MIP) will be measured at residual volume after maximum expiration. Measurements will be made twice in a sitting position with verbal encouragement and using a nose clip. The highest value obtained, with no more than 10% or 10cmH2O difference between the two measured values, will be used for analysis
Measured: 8 weeks
Respiratory Muscle Strength Measurement (Maximum Expiratory Pressure)
It will be used as the primary outcome measure in the study. In our study, respiratory muscle strength will be measured with a portable intraoral pressure measuring device (MicroRPM) Maximum static expiratory pressure (MEP) will be measured at maximum post-inspiratory total lung capacity.
Measurements will be made twice in a sitting position with verbal encouragement and using a nose clip. The highest value obtained, with no more than 10% or 10 cmH2O difference between the two measured values, will be used for analysis
Measured: 8 weeks
Thoracic Cage Mobility Assessment
Chest circumference measurements will be used to determine respiratory type. Measurements will be recorded in centimeters, using a tape measure, in an upright sitting position, from the axillary, epigastric and subcostal regions, the difference between neutral, deep inspiration and deep expiration
Measured: 8 weeks
Secondary outcomes (2)
Pulmonary Function Tests (PFT)
Pulmonary function tests will be performed with a spirometer device in the evaluation of pulmonary capacity. Pulmonary function tests are maneuvers applied to measure lung functions using standard devices. In this thesis, forced vital capacity (FVC), forced vital volume in one second (FEV1), FEV1/FVC and peak expiratory flow (PEF) values will be examined with pulmonary function tests.
Measured: 8 weeks
Gross Motor Functional Measurement (Part B)
Sitting skill will be evaluated with the sub-section B of the Gross Motor Function Measure (GMFM) test. Sitting, which is part B, consists of 20 items. The gross motor functions in these items are evaluated according to the degree of achievement of the function. Scoring is done on a Likert scale between 0 and 3 points. A score of 0 indicates that the activity could not be started at all, and 3 indicates that 90-100% of it can be done.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Oct 2022
- Primary completion2 Jan 2023
- Study completion2 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy Spastic DiplegiaStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Principal investigator, Berna Karamancıoğlu, Uskudar University
- Investigators
- Ozge Kenıs Coskun, PhD, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559346
- Sponsor's protocol ID
- CP1
- Status last verified
- Oct 2023
- First submitted
- 26 Sep 2022
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karamancioglu B, Coskun OK, Erdem-Eralp E, Gokdemir Y, Karadag-Saygi E. Effects of diaphragmatic breathing and manual diaphragm relaxation on respiratory muscle strength, chest expansion, pulmonary function, and sitting ability in children with diplegic cerebral palsy: A randomized controlled trial. J Pediatr Rehabil Med. 2026 May;19(2):110-122. doi: 10.1177/18758894261419624. Epub 2026 Feb 9.
PubMed 41664476
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Diaphragm Exercises in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05559346
- Acronym / sponsor ID
- CP1
- Conditions
- Cerebral Palsy Spastic Diplegia
- Keywords
- cerebral palsy, respiratory strength, pulmonary functions, sitting ability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 2 Jan 2023 (actual)
- Study completion
- 2 Jan 2023 (actual)
- First posted
- 29 Sep 2022 (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.
The aim of this study is to examine the effects of diaphragmatic myofascial relaxation exercise and diaphragmatic breathing exercises added to the conventional physiotherapy and rehabilitation program in children with diplegic cerebral palsy (CP), primarily on MIP, MEP, and secondarily on thoracic cage mobility, pulmonary functions and sitting ability.
Detailed description
This research is a randomized controlled trial. Volunteers diagnosed with cerebral palsy who applied to Marmara University Pendik Training and Research Hospital will participate in the research. A voluntary consent form will be obtained from the participants at the beginning of the study. Demographic and clinical information form will be filled for each patient at the beginning of the study before clinical evaluations. Demographic and clinical information form; Age, gender, height, weight, body mass index (BMI), how many weeks were born, birth weight, drug use, disease history, number of siblings, neonatal intensive care hospitalization history, education level of parents will be questioned. The Gross Motor Functional Classification System (KMFSS) will be used to determine the functionality levels of the volunteers who will participate in the study. The following tests will be applied to all of the volunteers who will participate in our study before and after the intervention:
Respiratory Muscle Strength Measurement Thoracic Cage Mobility Assessment Pulmonary Function Tests Gross Motor Functional Measurement (part B) Children meeting the inclusion criteria will be randomly assigned to two groups. The control and research groups will receive an individualized conventional rehabilitation program for 45 minutes, 2 days a week for 8 weeks. In addition to conventional rehabilitation, manual diaphragmatic relaxation exercises and diaphragmatic breathing exercises will be applied to the children in the research group two days a week.
After 8 weeks of intervention and control group applications, the evaluations made at the beginning of the intervention will be repeated. The evaluations of the two groups will be compared statistically and the results will be interpreted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Research Group | Experimental | Other: Diaphragmatic exercisesDiplegic Cerebral Palsy |
| Control Group | Active comparator | Other: conventional physiotherapyDiplegic Cerebral Palsy |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being diagnosed with spastic diplegic cerebral palsy
- Being between the ages of 5-15
- Gross Motor Functional Classification System 1,2 or 3
- To be at a cognitive level to be able to understand and apply the instructions in the tests (SFT, MIP, MEP) to be applied
Key exclusion criteria (4 listed)
- Having had a surgical operation in the last 6 months
- Presence of scoliosis detected above 30 degrees
- Having a planned surgery within 3 months from the start of the study
- Have a chronic lung disease
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 |
|---|---|---|
| Diaphragmatic exercisesDiaphragm exercises will be applied to the research group in addition to conventional rehabilitation.The content of the individualized conventional rehabilitation program consists of passive stretching exercises, strengthening exercises to antagonists of spastic muscles and exercises aimed at improving weight transfer, balance and correction reactions, and postural control. In addition to conventional rehabilitation, manual diaphragmatic relaxation exercises and diaphragmatic breathing exercises will be applied to the children in the research group two days a week. | Other | Research Group |
| conventional physiotherapyThe control group will only be taken to the conventional rehabilitation program. e content of the individualized conventional rehabilitation program consists of passive stretching exercises, strengthening exercises to antagonists of spastic muscles and exercises aimed at improving weight transfer, balance and correction reactions, and postural control. | Other | Control Group |
Primary outcome
Respiratory Muscle Strength Measurement (Maximum inspiratory pressure)
Time frame: 8 weeks
It will be used as the primary outcome measure in the study. In our study, respiratory muscle strength will be measured with a portable intraoral pressure measuring device (MicroRPM) Maximum static inspiratory pressure (MIP) will be measured at residual volume after maximum expiration. Measurements will be made twice in a sitting position with verbal encouragement and using a nose clip. The highest value obtained, with no more than 10% or 10cmH2O difference between the two measured values, will be used for analysis
Respiratory Muscle Strength Measurement (Maximum Expiratory Pressure)
Time frame: 8 weeks
It will be used as the primary outcome measure in the study. In our study, respiratory muscle strength will be measured with a portable intraoral pressure measuring device (MicroRPM) Maximum static expiratory pressure (MEP) will be measured at maximum post-inspiratory total lung capacity. Measurements will be made twice in a sitting position with verbal encouragement and using a nose clip. The highest value obtained, with no more than 10% or 10 cmH2O difference between the two measured values, will be used for analysis
Thoracic Cage Mobility Assessment
Time frame: 8 weeks
Chest circumference measurements will be used to determine respiratory type. Measurements will be recorded in centimeters, using a tape measure, in an upright sitting position, from the axillary, epigastric and subcostal regions, the difference between neutral, deep inspiration and deep expiration
2 secondary outcomes
Pulmonary Function Tests (PFT)
Time frame: 8 weeks
Gross Motor Functional Measurement (Part B)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Derived from this study: PubMed 41664476Karamancioglu B, Coskun OK, Erdem-Eralp E, Gokdemir Y, Karadag-Saygi E. Effects of diaphragmatic breathing and manual diaphragm relaxation on respiratory muscle strength, chest expansion, pulmonary function, and sitting ability in children with diplegic cerebral palsy: A randomized controlled trial. J Pediatr Rehabil Med. 2026 May;19(2):110-122. doi: 10.1177/18758894261419624. Epub 2026 Feb 9.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ozge Kenıs Coskun, PhD study director
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic exercises and conventional physiotherapy in people with Cerebral Palsy Spastic Diplegia, run by Uskudar 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: finished, as of the sponsor's last update on 26 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Muscle Strength Measurement (Maximum inspiratory pressure) (time frame: 8 weeks). The study lists 3 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 NCT05559346, which also lists 1 linked publication.
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 26 Oct 2023.