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

February 3, 2026 updated by: İrem Çetinkaya, Halic University

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:

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.

Study Overview

Status

Not yet recruiting

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 Type

Observational

Enrollment (Estimated)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

Baseline (single assessment session)
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

Baseline (single assessment session)
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

Baseline (single assessment session)
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

Baseline (single assessment session)
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

Baseline (single assessment session)
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

Baseline (single assessment session)
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.

Baseline (single assessment session)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score on the ABILHAND-Kids Questionnaire
Time Frame: Baseline (single assessment session)

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.

Baseline (single assessment session)
Number of Blocks Transferred in Sixty Seconds During the Box and Block Test
Time Frame: Baseline (single assessment session)

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.

Baseline (single assessment session)
Classification Level on the Gross Motor Function Classification System
Time Frame: Baseline (single assessment session)

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.

Baseline (single assessment session)
Mean Hand Grip Strength of the Affected Hand Measured With a Hand Dynamometer
Time Frame: Baseline (single assessment session)

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

Baseline (single assessment session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: İrem Çetinkaya, PhD, Halic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 23, 2026

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 9, 2026

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Palsy

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