Cerebral PalsyNCT07394439
Respiratory Function, Respiratory Muscle Strength, and Hand Function in Hemiparetic Cerebral Palsy
An observational study of Cerebral Palsy and Respiratory Function Tests, run by Halic University.
Trial summary
The goal of this observational study is to learn how respiratory function and respiratory muscle strength are related to hand use in children and teenagers with hemiparetic cerebral palsy (CP) aged 6 to 18 years. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy, Respiratory Function Tests, Fine Motor Skills
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 23 Jan 2026to 9 Mar 2026
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents aged 6-18 years with a physician-confirmed diagnosis of hemiparetic cerebral palsy, recruited from outpatient pediatric rehabilitation clinics and physiotherapy centers. Participants will be individuals receiving routine follow-up or rehabilitation services who meet the study eligibility criteria and are able to complete respiratory and hand function assessments.
Who may be able to join
- Confirmed diagnosis of hemiparetic cerebral palsy by a physician.
- Sufficient cognitive ability to understand and follow test instructions, as judged by a parent or clinician.
- Clinically stable condition for at least 3 months, with no changes in medication, acute exacerbations, or modifications in rehabilitation programs.
- Physical capacity sufficient to tolerate pulmonary function testing (spirometry), maximum inspiratory/expiratory pressure (MIP/MEP) measurements, and other study assessments.
Who cannot join
- Current or recent acute respiratory infection, asthma exacerbation, pneumonia, or known cardiopulmonary disease that may affect testing.
- Receipt of intensive upper extremity interventions other than routine physiotherapy (e.g., botulinum toxin injections, surgical procedures) within the past 6 months.
- History of major orthopedic surgery (e.g., hip reconstruction, scoliosis surgery) within the past 3 months.
- Severe musculoskeletal contracture or deformity that prevents the safe performance of pulmonary function testing.
- Severe epilepsy, uncontrolled seizures, or other neurological conditions that may compromise safety during testing.
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: Association of Respiratory Function and Respiratory Muscle Strength With Hand Function in Children With Hemiparetic Cerebral Palsy
The goal of this observational study is to learn how respiratory function and respiratory muscle strength are related to hand use in children and teenagers with hemiparetic cerebral palsy (CP) aged 6 to 18 years.
The main questions it aims to answer are:
Read more
Is respiratory function related to hand function in children with hemiparetic CP? Is respiratory muscle strength related to hand function in children with hemiparetic CP? Is respiratory function related to how strong children can squeeze with their affected hand? Is respiratory muscle strength related to how strong children can squeeze with their affected hand? Is respiratory function related to how well children use their hands in daily activities? Is respiratory muscle strength related to how well children use their hands in daily activities? Is respiratory function related to children's hand skill level? Is respiratory muscle strength related to children's hand skill level?
Participants will:
Visit the clinic one time for a single assessment session. Do simple lung tests using a small portable device to measure respiratory function.
Do tests that measure how strong their breathing muscles are.
Complete hand and arm tests, including:
A hand grip strength test, A simple block-moving test, A short questionnaire about using the hand in daily life, A standard hand skill rating. Researchers will look at how respiratory measures are related to hand strength, hand skills, and daily hand use. This study may help improve rehabilitation programs by showing whether respiratory muscle strength and hand skills should be trained together in children with hemiparetic CP.
Read the detailed description
Hemiparetic cerebral palsy (CP) is associated with asymmetric motor impairments that may affect trunk stability, respiratory mechanics, and hand function. This observational, cross-sectional study aims to examine the relationship between respiratory function, respiratory muscle strength, and hand function in children with hemiparetic CP.
The study will include at least 37 participants aged 6 to 18 years with a diagnosis of hemiparetic CP. Demographic and clinical characteristics will be recorded. Respiratory function will be assessed using a portable spirometer, and respiratory muscle strength will be measured by maximum inspiratory and expiratory pressures. Hand function will be evaluated using grip strength (Jamar dynamometer), gross manual dexterity (Box and Block Test), functional hand use in daily activities (ABILHAND-Kids), and manual ability level (MACS).
All assessments will be conducted in a single session under standardized conditions by the same physiotherapist. Data will be analyzed using descriptive statistics and Pearson or Spearman correlation tests. Comparisons between different functional levels will also be performed.
The findings are expected to clarify the interaction between respiratory capacity and upper extremity function and to support comprehensive rehabilitation approaches targeting both hand skills and respiratory muscle strength in children with hemiparetic CP.
- Keywords
- Hemiparetic Cerebral Palsy, Respiratory Function, Respiratory Muscle Strength, Hand Function
- Medical subject headings
- Cerebral Palsy, Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Inspiratory Pressure
Respiratory muscle strength related to inspiration will be assessed in accordance with the joint recommendations of the American Thoracic Society and the European Respiratory Society. Measurements will be performed using a portable electronic respiratory pressure device (Cosmed Pony Fx, Rome, Italy). Participants will wear a mouthpiece and a nose clip to prevent air leakage. After full expiration, participants will perform a maximal inspiratory effort. The measurement will be repeated three times, and the highest value will be recorded for analysis.
Outcome Measure Units cmH2O
Measured: Baseline (single assessment session)
Maximum Expiratory Pressure
Respiratory muscle strength related to expiration will be assessed in accordance with the joint recommendations of the American Thoracic Society and the European Respiratory Society. Measurements will be performed using the same portable electronic respiratory pressure device. Participants will wear a mouthpiece and a nose clip to prevent air leakage. After full inspiration, participants will perform a maximal expiratory effort. The measurement will be repeated three times, and the highest value will be recorded for analysis.
Outcome Measure Units cmH2O
Measured: Baseline (single assessment session)
Forced Vital Capacity
Pulmonary function will be assessed by spirometry in accordance with the standards of the American Thoracic Society and the European Respiratory Society using a portable spirometer (COSMED Pony Fx, Rome, Italy). Measurements will be performed in a seated position with back support while participants wear a nose clip. Participants will take a maximal inspiration followed by a forceful, maximal expiration. Three trials will be performed, and the highest acceptable value will be recorded for analysis.
Unit of Measure liters
Measured: Baseline (single assessment session)
Forced Expiratory Volume in One Second
Pulmonary function will be assessed using the same spirometry procedure and equipment. The volume of air exhaled during the first second of a forced expiration will be recorded. Three trials will be performed, and the highest acceptable value will be used for analysis.
Unit of Measure liters
Measured: Baseline (single assessment session)
Ratio of Forced Expiratory Volume in One Second to Forced Vital Capacity Ratio
Pulmonary function will be assessed using the same spirometry procedure and equipment. The ratio between the forced expiratory volume in one second and the forced vital capacity will be calculated from the best acceptable maneuver and recorded for analysis.
Unit of Measure percent
Measured: Baseline (single assessment session)
Peak Expiratory Flow Rate
Pulmonary function will be assessed using the same spirometry procedure and equipment. The highest expiratory flow achieved during the forced expiration maneuver will be recorded. Three trials will be performed, and the highest acceptable value will be used for analysis.
Unit of Measure liters per second
Measured: Baseline (single assessment session)
Classification Level on the Manual Ability Classification System
Manual ability will be classified using the Manual Ability Classification System (MACS), a five-level classification system that describes how children with cerebral palsy use their hands during daily activities.
Level I represents the most independent hand use. Level V represents the most severe limitation in manual ability. The MACS is applicable to children aged 4 to 18 years and has been validated in Turkish (Cansoy et al., 2014). In this study, MACS will be used to determine the participant's baseline level of manual ability.
Measured: Baseline (single assessment session)
Secondary outcomes (4)
Score on the ABILHAND-Kids Questionnaire
Functional use of the hand in daily activities will be assessed using the ABILHAND-Kids questionnaire, a parent-reported scale developed for children aged 6 to 15 years. The scale consists of 21 items, each rated as "easy," "difficult," or "impossible" based on the child's ability to perform bimanual daily activities.
The scale is based on Rasch analysis and specifically designed for use in children with cerebral palsy. A validated Turkish version is available, and permission for its use has been requested.
Measured: Baseline (single assessment session)
Number of Blocks Transferred in Sixty Seconds During the Box and Block Test
Gross manual dexterity will be assessed using the Box and Block Test (BBT), a widely used measure of upper extremity gross manual function in both pediatric and adult populations. The test evaluates basic components of manual dexterity, including grasping, holding, transferring, and releasing objects.
The BBT consists of a wooden box (53.7 × 25.4 × 8.5 cm) divided into two equal compartments by a partition, with 150 wooden cubes (2.5 cm per side) placed in one compartment. Participants will be instructed to transfer as many blocks as possible from one compartment to the other within 60 seconds. The number of blocks transferred will be counted by the examiner using a stopwatch.
The test will be administered separately for each hand, and the total number of blocks transferred in 60 seconds will be recorded for analysis.
Measured: Baseline (single assessment session)
Classification Level on the Gross Motor Function Classification System
Gross motor function level will be classified using the Gross Motor Function Classification System (GMFCS), an internationally accepted five-level system that describes the gross motor abilities and level of independence of children with cerebral palsy.
Level I: Walks without limitations. Level II: Walks with limitations. Level III: Walks using a hand-held mobility device. Level IV: Self-mobility with limitations; may use powered mobility. Level V: Transported in a manual wheelchair.
Measured: Baseline (single assessment session)
Mean Hand Grip Strength of the Affected Hand Measured With a Hand Dynamometer
Grip strength of the affected hand will be measured using a Jamar hand dynamometer, which is considered the gold standard for grip strength assessment and is recommended by the American Society of Hand Therapists.
Participants will be seated with:
Shoulder in adduction, Elbow flexed at 90°, Forearm in neutral position, Wrist in neutral alignment. The affected hand will be tested three times, and the mean of the three trials will be used for analysis.
Outcome Measure Units: Kilograms
Measured: Baseline (single assessment session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start23 Jan 2026 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion9 Mar 2026 (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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İrem Çetinkaya, Halic University
- Investigators
- İrem Çetinkaya, PhD, Principal investigator, Haliç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394439
- Sponsor's protocol ID
- Acetinkaya009
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2026
- Last updated
- 6 Feb 2026
- 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Respiratory Function and Respiratory Muscle Strength With Hand Function in Children With Hemiparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07394439
- Acronym / sponsor ID
- Acetinkaya009
- Keywords
- Hemiparetic Cerebral Palsy, Respiratory Function, Respiratory Muscle Strength, Hand Function
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 23 Jan 2026 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 9 Mar 2026 (estimated)
- First posted
- 6 Feb 2026 (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 goal of this observational study is to learn how respiratory function and respiratory muscle strength are related to hand use in children and teenagers with hemiparetic cerebral palsy (CP) aged 6 to 18 years.
The main questions it aims to answer are:
Is respiratory function related to hand function in children with hemiparetic CP? Is respiratory muscle strength related to hand function in children with hemiparetic CP? Is respiratory function related to how strong children can squeeze with their affected hand? Is respiratory muscle strength related to how strong children can squeeze with their affected hand? Is respiratory function related to how well children use their hands in daily activities? Is respiratory muscle strength related to how well children use their hands in daily activities? Is respiratory function related to children's hand skill level? Is respiratory muscle strength related to children's hand skill level?
Participants will:
Visit the clinic one time for a single assessment session. Do simple lung tests using a small portable device to measure respiratory function.
Do tests that measure how strong their breathing muscles are.
Complete hand and arm tests, including:
A hand grip strength test, A simple block-moving test, A short questionnaire about using the hand in daily life, A standard hand skill rating. Researchers will look at how respiratory measures are related to hand strength, hand skills, and daily hand use. This study may help improve rehabilitation programs by showing whether respiratory muscle strength and hand skills should be trained together in children with hemiparetic CP.
Detailed description
Hemiparetic cerebral palsy (CP) is associated with asymmetric motor impairments that may affect trunk stability, respiratory mechanics, and hand function. This observational, cross-sectional study aims to examine the relationship between respiratory function, respiratory muscle strength, and hand function in children with hemiparetic CP.
The study will include at least 37 participants aged 6 to 18 years with a diagnosis of hemiparetic CP. Demographic and clinical characteristics will be recorded. Respiratory function will be assessed using a portable spirometer, and respiratory muscle strength will be measured by maximum inspiratory and expiratory pressures. Hand function will be evaluated using grip strength (Jamar dynamometer), gross manual dexterity (Box and Block Test), functional hand use in daily activities (ABILHAND-Kids), and manual ability level (MACS).
All assessments will be conducted in a single session under standardized conditions by the same physiotherapist. Data will be analyzed using descriptive statistics and Pearson or Spearman correlation tests. Comparisons between different functional levels will also be performed.
The findings are expected to clarify the interaction between respiratory capacity and upper extremity function and to support comprehensive rehabilitation approaches targeting both hand skills and respiratory muscle strength in children with hemiparetic CP.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents aged 6-18 years with a physician-confirmed diagnosis of hemiparetic cerebral palsy, recruited from outpatient pediatric rehabilitation clinics and physiotherapy centers. Participants will be individuals receiving routine follow-up or rehabilitation services who meet the study eligibility criteria and are able to complete respiratory and hand function assessments.
Key inclusion criteria (4 listed)
- Confirmed diagnosis of hemiparetic cerebral palsy by a physician.
- Sufficient cognitive ability to understand and follow test instructions, as judged by a parent or clinician.
- Clinically stable condition for at least 3 months, with no changes in medication, acute exacerbations, or modifications in rehabilitation programs.
- Physical capacity sufficient to tolerate pulmonary function testing (spirometry), maximum inspiratory/expiratory pressure (MIP/MEP) measurements, and other study assessments.
Key exclusion criteria (5 listed)
- Current or recent acute respiratory infection, asthma exacerbation, pneumonia, or known cardiopulmonary disease that may affect testing.
- Receipt of intensive upper extremity interventions other than routine physiotherapy (e.g., botulinum toxin injections, surgical procedures) within the past 6 months.
- History of major orthopedic surgery (e.g., hip reconstruction, scoliosis surgery) within the past 3 months.
- Severe musculoskeletal contracture or deformity that prevents the safe performance of pulmonary function testing.
- Severe epilepsy, uncontrolled seizures, or other neurological conditions that may compromise safety during testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximum Inspiratory Pressure
Time frame: Baseline (single assessment session)
Respiratory muscle strength related to inspiration will be assessed in accordance with the joint recommendations of the American Thoracic Society and the European Respiratory Society. Measurements will be performed using a portable electronic respiratory pressure device (Cosmed Pony Fx, Rome, Italy). Participants will wear a mouthpiece and a nose clip to prevent air leakage. After full expiration, participants will perform a maximal inspiratory effort. The measurement will be repeated three times, and the highest value will be recorded for analysis. Outcome Measure Units cmH2O
Maximum Expiratory Pressure
Time frame: Baseline (single assessment session)
Respiratory muscle strength related to expiration will be assessed in accordance with the joint recommendations of the American Thoracic Society and the European Respiratory Society. Measurements will be performed using the same portable electronic respiratory pressure device. Participants will wear a mouthpiece and a nose clip to prevent air leakage. After full inspiration, participants will perform a maximal expiratory effort. The measurement will be repeated three times, and the highest value will be recorded for analysis. Outcome Measure Units cmH2O
Forced Vital Capacity
Time frame: Baseline (single assessment session)
Pulmonary function will be assessed by spirometry in accordance with the standards of the American Thoracic Society and the European Respiratory Society using a portable spirometer (COSMED Pony Fx, Rome, Italy). Measurements will be performed in a seated position with back support while participants wear a nose clip. Participants will take a maximal inspiration followed by a forceful, maximal expiration. Three trials will be performed, and the highest acceptable value will be recorded for analysis. Unit of Measure liters
Forced Expiratory Volume in One Second
Time frame: Baseline (single assessment session)
Pulmonary function will be assessed using the same spirometry procedure and equipment. The volume of air exhaled during the first second of a forced expiration will be recorded. Three trials will be performed, and the highest acceptable value will be used for analysis. Unit of Measure liters
Ratio of Forced Expiratory Volume in One Second to Forced Vital Capacity Ratio
Time frame: Baseline (single assessment session)
Pulmonary function will be assessed using the same spirometry procedure and equipment. The ratio between the forced expiratory volume in one second and the forced vital capacity will be calculated from the best acceptable maneuver and recorded for analysis. Unit of Measure percent
Peak Expiratory Flow Rate
Time frame: Baseline (single assessment session)
Pulmonary function will be assessed using the same spirometry procedure and equipment. The highest expiratory flow achieved during the forced expiration maneuver will be recorded. Three trials will be performed, and the highest acceptable value will be used for analysis. Unit of Measure liters per second
Classification Level on the Manual Ability Classification System
Time frame: Baseline (single assessment session)
Manual ability will be classified using the Manual Ability Classification System (MACS), a five-level classification system that describes how children with cerebral palsy use their hands during daily activities. Level I represents the most independent hand use. Level V represents the most severe limitation in manual ability. The MACS is applicable to children aged 4 to 18 years and has been validated in Turkish (Cansoy et al., 2014). In this study, MACS will be used to determine the participant's baseline level of manual ability.
4 secondary outcomes
Score on the ABILHAND-Kids Questionnaire
Time frame: Baseline (single assessment session)
Number of Blocks Transferred in Sixty Seconds During the Box and Block Test
Time frame: Baseline (single assessment session)
Classification Level on the Gross Motor Function Classification System
Time frame: Baseline (single assessment session)
Mean Hand Grip Strength of the Affected Hand Measured With a Hand Dynamometer
Time frame: Baseline (single assessment session)
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 6 Feb 2026.
- 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.
İrem Çetinkaya, PhD principal investigator
Haliç University
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Respiratory Function Tests, run by Halic 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 4 inclusion and 5 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 6 Feb 2026. 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. 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 Emine Kılıç (+905548056805, 22151010274@ogr.halic.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Inspiratory Pressure (time frame: Baseline (single assessment session)). 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 6 Feb 2026.