Respiratory Function, Respiratory Muscle Strength, and Hand Function in Hemiparetic Cerebral Palsy

NCT07394439 | Not Yet Recruiting

• 1 other identifier: Acetinkaya009
• Study Type: observational
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Cerebral Palsy; Respiratory Function Tests; Fine Motor Skills

Keywords

Hemiparetic Cerebral Palsy; Respiratory Function; Respiratory Muscle Strength; Hand Function

Outcome Measures

Primary Outcomes (7)

• 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

  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

  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

  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

  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

  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

  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.

  Baseline (single assessment session)

Secondary Outcomes (4)

• Score on the ABILHAND-Kids Questionnaire

  Baseline (single assessment session)

• Number of Blocks Transferred in Sixty Seconds During the Box and Block Test

  Baseline (single assessment session)

• Classification Level on the Gross Motor Function Classification System

  Baseline (single assessment session)

• Mean Hand Grip Strength of the Affected Hand Measured With a Hand Dynamometer

  Baseline (single assessment session)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Halic University: lead

MeSH Terms

Conditions

Cerebral Palsy; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• İrem Çetinkaya, PhD

  Haliç University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emine Kılıç

CONTACT

+905548056805; 22151010274@ogr.halic.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 6, 2026
• Study Start: January 23, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 9, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share