Respiratory Function, Respiratory Muscle Strength, and Hand Function in Hemiparetic Cerebral Palsy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorHalic University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline (single assessment session)2
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
Time frame
Baseline (single assessment session)3
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
Time frame
Baseline (single assessment session)4
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
Time frame
Baseline (single assessment session)Secondary outcomes
1
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.
Time frame
Baseline (single assessment session)2
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.
Time frame
Baseline (single assessment session)3
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.
Time frame
Baseline (single assessment session)4
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
Time frame
Baseline (single assessment session)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: