Cerebral PalsyNCT06840626
Pilot Study on Breathing Exercises and Pulmonary Function in Children With Cerebral Palsy: A Randomized Trial
A study testing Series of breathing exercises in people with Cerebral Palsy, run by Semmelweis University at 1 site in Hungary.
Trial summary
This pilot study is a randomized controlled trial aimed at investigating the efficacy of protocolized conductive breathing exercises combined with regular air ventilation, in addition to standard care, on various aspects of health in school-aged children with cerebral palsy (CP). Read more about this study
- Who is it for?
- Ages 12 to 22 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Series of breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteHungary
- Study dates
- 15 Apr 2024to 30 Mar 2025
- 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 12 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with cerebral palsy (GMFCS I-V)
- School-Aged 12-22 years, of both genders
- Teens and adolescents attending continuous standard care
- Capable of understanding and following commands given by the therapist
- Children who do not require respiratory support
Who cannot join
- Children who have received recent surgical procedures or botulinum toxin injections
- Children who are unable to perform spirometry
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University, Conductive Pedagogical Methodology Institution and College.
Budapest, Pest County, 1125
About this study
Official title: Pilot Study on the Effects of Conductive Breathing Exercises on Pulmonary Function in School-Aged Children With Cerebral Palsy: A Randomized Controlled Trial
This pilot study is a randomized controlled trial aimed at investigating the efficacy of protocolized conductive breathing exercises combined with regular air ventilation, in addition to standard care, on various aspects of health in school-aged children with cerebral palsy (CP). The primary objectives of the study include assessing the effects on pulmonary functions, quality of life (QoL), depression anxiety and stress (DAS) levels, eating-drinking ability (EDACS), and severity of drooling in this population.
The study compares two groups of participants: one group undergoes protocolized conductive breathing exercises three times per day for five minutes, five days a week, while the other group receives only standard rehabilitation care. Evaluations include spirometry parameters ( forced vital capacity [FVC] forced expiratory volume in the first second [FEV1], FEV1/FVC ratio and peak expiratory flow [PEF]. Assessments are conducted at the beginning and end of the eight weeks intervention period, with additional evaluations after a 2.5-month washout period.
Read more
The conductive breathing exercises, developed by Dr. András Pető, the founder of the conductive education system, consist of techniques such as diaphragmatic breathing, deep breathing, and playful forced expiration.
Respiratory well-being is crucial, particularly in pediatric CP patients, as compromised pulmonary functions can significantly impact overall health. Despite this, there is currently a lack of established protocols and research regarding the efficacy of conductive breathing exercises in this specific population. Therefore, the this study seeks to address this gap by determining whether a structured regimen of conductive breathing exercises, when added to standard care, can lead to measurable improvements in respiratory health and QoL among school-aged children with CP.
- Conditions
- Cerebral Palsy
- Being tested
- Series of breathing exercises
- Keywords
- cerebral palsy, respiratory health, spirometry, CP quality of life
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Series of breathing exercisesOther
During the intervention, participants perform respiratory exercises, including deep breathing, belly breathing, exhalation with vocalization, and forced exhalation. Each exercise is repeated five times, three times per day: twice in the morning and once in the afternoon. The exercises are conducted in a seated, corrected position, guided by rehabilitation specialists or special needs teachers who provide instructions and demonstrations. Teachers are provided with the exact protocol for the breathing exercises series. Each breathing exercise focuses on maintaining a specific rhythm, with inhalation lasting approximately 3-4 seconds, holding for 1-2 seconds, and exhalation for 5-6 seconds. Forced exhalation is facilitated using playful motivational tools such as windmills and balloon blowing. The protocol includes instructions for the breathing exercises in first-person singular. The entire session lasts approximately 5 minutes, resulting in a total of 15 minutes of training per day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | In this group, participants received conductive education as standard rehabilitation care plus the procolized breathing exercesis. In this group, participants followed a strict protocol for breathing exercises over an 8-week period, performing them three times a day, Monday through Friday, for five minutes each session. They also adhered to prescribed ventilation guidelines, in addition to receiving standard rehabilitation care. Receives: Other: Series of breathing exercises |
| Control Arm | No intervention | In this group, participants received conductive education as standard rehabilitation care plus sham breathing exercises. Participants in this group followed a strict 8-week protocol for breathing exercises, which included a sham breathing protocol, performing the exercises three times a day, Monday through Friday, for one minutes each session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1st second (FEV1) in (L)
Change from baseline in forced expiratory volume in 1st second (FEV1)
- Description: FEV1 is the maximal volume of air that can be expired in the first second of forced vital capacity maneuver using spirometry.
- Units of Measure: L (Liter)
Measured: • Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
Forced Expiratory Volume in 1st second (FEV1) in %
Change from baseline in forced expiratory volume in 1st second (FEV1)
- Units of Measure: Percentage (%) The mentioned outcome will be measured using a spirometer and calculated according to the Quanjer, 1993 (ECCS) standards.
Measured: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
Forced Vital Capacity (FVC) in (L)
- Description: FVC is the maximal volume of air that can be forcefully exhaled after taking the deepest breath possible, measured using spirometry.
- Units of Measure: L (Liter)
Measured: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
Forced Vital Capacity (FVC) in %
FVC is the maximal volume of air that can be forcefully exhaled after taking the deepest breath possible, measured using spirometry.
- Units of Measure: Percentage (%)
The mentioned outcome will be measured using a spirometer and calculated according to the Quanjer, 1993 (ECCS) standards:
Measured: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
FEV1/FVC Ratio
Description: This is already a combined measurement (a ratio of Forced Expiratory Volume in the first second to Forced Vital Capacity).
No unit.
Measured: Measured at 0, 8, and 18 weeks.
Peak Expiratory Flow (PEF) in (L/sec)
Description: Peak Expiratory Flow (PEF) is the highest speed at which air can be forcefully exhaled from the lungs after taking the deepest breath possible, measured using spirometry.
Units of Measure: L/sec (Liter/secundum)
Measured: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
Peak Expiratory Flow (PEF) in %
Description: Peak Expiratory Flow (PEF) is the highest speed at which air can be forcefully exhaled from the lungs after taking the deepest breath possible, measured using spirometry. • Units of Measure: Percentage (%) The mentioned outcome will be measured using a spirometer and calculated according to the Quanjer, 1993 (ECCS) standards.
Measured: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
Secondary outcomes (7)
Cerebral Palsy Quality of Life
The CP QoL test measures changes in quality of life (QoL) across different domains, such as social and emotional well-being, acceptance, bodily pain, and functioning. The assessment is conducted at three time points: 0 weeks, 8 weeks, and 18 weeks.
Scoring and Interpretation:
Scale: Scores are recorded from 1 to 9, where 1 = Very unhappy and 9 = Very happy. Higher scores indicate better quality of life (QoL).
Measured: measurement at 0 weeks, 8 weeks, 18 weeks
Severity and Frequency of Drooling
The severity and frequency of drooling will be assessed for changes.
Measured: measurement at 0 weeks, 8 weeks, 18 weeks
Depression level
Depression Scale (DAS-D): Measures symptoms of depression such as low mood, hopelessness, and loss of interest.
- Scale Details:
- Minimum Score: [0]
- Maximum Score: [28]
In this scale, higher scores represent worse outcomes (indicating more severe depression symptoms), while lower scores reflect better mental health (indicating fewer or less severe symptoms of depression).
Measured: measurement at 0 weeks, 8 weeks, 18 weeks
Anxiety level
Anxiety Scale (DAS-A): Assesses symptoms related to anxiety, including nervousness, panic, and fear.
Scale Details:
- Minimum Score: [0]
- Maximum Score: [20] In this scale, higher scores represent worse outcomes (indicating more severe anxiety symptoms), while lower scores reflect better mental health (indicating fewer or less severe symptoms of anxiety).
Measured: measurement at 0 weeks, 8 weeks, 18 weeks
Stress level
Stress Scale (DAS-S): Evaluates stress-related symptoms like irritability, tension, and difficulty relaxing.
Scale Details:
- Minimum Score: [0]
- Maximum Score: [34] In this scale, higher scores represent worse outcomes (indicating more severe stress symptoms), while lower scores reflect better mental health (indicating fewer or less severe symptoms of stress).
Measured: measurement at 0 weeks, 8 weeks, 18 weeks
Eating Ability
Measured with EDACS test, changes in Eating and Drinking Ability, encompassing oral-motor skills, pharyngeal function, eating skills, and drinking skills. It assesses the coordination of mouth, tongue, and jaw movements, swallowing function, food preparation, grasping, and consumption of both food and liquids.
Measured: measurement at 0 weeks, 8 weeks, 18 weeks
Drinking Ability
Measured with EDACS test, changes in Eating and Drinking Ability, encompassing oral-motor skills, pharyngeal function, eating skills, and drinking skills. It assesses the coordination of mouth, tongue, and jaw movements, swallowing function, food preparation, grasping, and consumption of both food and liquids.
Measured: measurement at 0 weeks, 8 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start15 Apr 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Model description
- The study compares two groups of participants: one group undergoes protocolized conductive breathing exercises three times per day for five minutes, five days a week, while the other group receives only standard rehabilitation care.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Translational Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840626
- Sponsor's protocol ID
- SE11568780
- Status last verified
- May 2024
- First submitted
- 29 Jan 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effects of Conductive Breathing Exercises on Pulmonary Function in School-Aged Children With Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06840626
- Acronym / sponsor ID
- SE11568780
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, respiratory health, spirometry, CP quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Collaborators
- Center for Translational Medicine
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 21 Feb 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 pilot study is a randomized controlled trial aimed at investigating the efficacy of protocolized conductive breathing exercises combined with regular air ventilation, in addition to standard care, on various aspects of health in school-aged children with cerebral palsy (CP). The primary objectives of the study include assessing the effects on pulmonary functions, quality of life (QoL), depression anxiety and stress (DAS) levels, eating-drinking ability (EDACS), and severity of drooling in this population.
The study compares two groups of participants: one group undergoes protocolized conductive breathing exercises three times per day for five minutes, five days a week, while the other group receives only standard rehabilitation care. Evaluations include spirometry parameters ( forced vital capacity [FVC] forced expiratory volume in the first second [FEV1], FEV1/FVC ratio and peak expiratory flow [PEF]. Assessments are conducted at the beginning and end of the eight weeks intervention period, with additional evaluations after a 2.5-month washout period.
The conductive breathing exercises, developed by Dr. András Pető, the founder of the conductive education system, consist of techniques such as diaphragmatic breathing, deep breathing, and playful forced expiration.
Respiratory well-being is crucial, particularly in pediatric CP patients, as compromised pulmonary functions can significantly impact overall health. Despite this, there is currently a lack of established protocols and research regarding the efficacy of conductive breathing exercises in this specific population. Therefore, the this study seeks to address this gap by determining whether a structured regimen of conductive breathing exercises, when added to standard care, can lead to measurable improvements in respiratory health and QoL among school-aged children with CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The study compares two groups of participants: one group undergoes protocolized conductive breathing exercises three times per day for five minutes, five days a week, while the other group receives only standard rehabilitation care.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Series of breathing exercisesIn this group, participants received conductive education as standard rehabilitation care plus the procolized breathing exercesis. In this group, participants followed a strict protocol for breathing exercises over an 8-week period, performing them three times a day, Monday through Friday, for five minutes each session. They also adhered to prescribed ventilation guidelines, in addition to receiving standard rehabilitation care. |
| Control Arm | No intervention | –In this group, participants received conductive education as standard rehabilitation care plus sham breathing exercises. Participants in this group followed a strict 8-week protocol for breathing exercises, which included a sham breathing protocol, performing the exercises three times a day, Monday through Friday, for one minutes each session. |
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Children with cerebral palsy (GMFCS I-V)
- School-Aged 12-22 years, of both genders
- Teens and adolescents attending continuous standard care
- Capable of understanding and following commands given by the therapist
- Children who do not require respiratory support
Key exclusion criteria (2 listed)
- Children who have received recent surgical procedures or botulinum toxin injections
- Children who are unable to perform spirometry
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 |
|---|---|---|
| Series of breathing exercisesDuring the intervention, participants perform respiratory exercises, including deep breathing, belly breathing, exhalation with vocalization, and forced exhalation. Each exercise is repeated five times, three times per day: twice in the morning and once in the afternoon. The exercises are conducted in a seated, corrected position, guided by rehabilitation specialists or special needs teachers who provide instructions and demonstrations. Teachers are provided with the exact protocol for the breathing exercises series. Each breathing exercise focuses on maintaining a specific rhythm, with inhalation lasting approximately 3-4 seconds, holding for 1-2 seconds, and exhalation for 5-6 seconds. Forced exhalation is facilitated using playful motivational tools such as windmills and balloon blowing. The protocol includes instructions for the breathing exercises in first-person singular. The entire session lasts approximately 5 minutes, resulting in a total of 15 minutes of training per day. | Other | Intervention Arm |
Primary outcome
Forced Expiratory Volume in 1st second (FEV1) in (L)
Time frame: • Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
Change from baseline in forced expiratory volume in 1st second (FEV1) * Description: FEV1 is the maximal volume of air that can be expired in the first second of forced vital capacity maneuver using spirometry. * Units of Measure: L (Liter)
Forced Expiratory Volume in 1st second (FEV1) in %
Time frame: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
Change from baseline in forced expiratory volume in 1st second (FEV1) • Units of Measure: Percentage (%) The mentioned outcome will be measured using a spirometer and calculated according to the Quanjer, 1993 (ECCS) standards.
Forced Vital Capacity (FVC) in (L)
Time frame: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
* Description: FVC is the maximal volume of air that can be forcefully exhaled after taking the deepest breath possible, measured using spirometry. * Units of Measure: L (Liter)
Forced Vital Capacity (FVC) in %
Time frame: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
FVC is the maximal volume of air that can be forcefully exhaled after taking the deepest breath possible, measured using spirometry. • Units of Measure: Percentage (%) The mentioned outcome will be measured using a spirometer and calculated according to the Quanjer, 1993 (ECCS) standards:
FEV1/FVC Ratio
Time frame: Measured at 0, 8, and 18 weeks.
Description: This is already a combined measurement (a ratio of Forced Expiratory Volume in the first second to Forced Vital Capacity). No unit.
Peak Expiratory Flow (PEF) in (L/sec)
Time frame: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
Description: Peak Expiratory Flow (PEF) is the highest speed at which air can be forcefully exhaled from the lungs after taking the deepest breath possible, measured using spirometry. Units of Measure: L/sec (Liter/secundum)
Peak Expiratory Flow (PEF) in %
Time frame: Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks
Description: Peak Expiratory Flow (PEF) is the highest speed at which air can be forcefully exhaled from the lungs after taking the deepest breath possible, measured using spirometry. • Units of Measure: Percentage (%) The mentioned outcome will be measured using a spirometer and calculated according to the Quanjer, 1993 (ECCS) standards.
7 secondary outcomes
Cerebral Palsy Quality of Life
Time frame: measurement at 0 weeks, 8 weeks, 18 weeks
Severity and Frequency of Drooling
Time frame: measurement at 0 weeks, 8 weeks, 18 weeks
Depression level
Time frame: measurement at 0 weeks, 8 weeks, 18 weeks
Anxiety level
Time frame: measurement at 0 weeks, 8 weeks, 18 weeks
Stress level
Time frame: measurement at 0 weeks, 8 weeks, 18 weeks
Eating Ability
Time frame: measurement at 0 weeks, 8 weeks, 18 weeks
Drinking Ability
Time frame: measurement at 0 weeks, 8 weeks, 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Series of breathing exercises in people with Cerebral Palsy, run by Semmelweis University at 1 site in Hungary.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Feb 2025. 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 Hungary. 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?
Results are not available in the source record.
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?
Forced Expiratory Volume in 1st second (FEV1) in (L) (time frame: • Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2025.