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

Официальное название

Association of Respiratory Function and Respiratory Muscle Strength With Hand Function in Children With Hemiparetic Cerebral Palsy

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Maximum Inspiratory Pressure [Срок оценки: Baseline (single assessment session)]
• Maximum Expiratory Pressure [Срок оценки: Baseline (single assessment session)]
• Forced Vital Capacity [Срок оценки: Baseline (single assessment session)]
• Forced Expiratory Volume in One Second [Срок оценки: Baseline (single assessment session)]
• Ratio of Forced Expiratory Volume in One Second to Forced Vital Capacity Ratio [Срок оценки: Baseline (single assessment session)]
• Peak Expiratory Flow Rate [Срок оценки: Baseline (single assessment session)]
• Classification Level on the Manual Ability Classification System [Срок оценки: Baseline (single assessment session)]

Вторичные конечные точки (4)

• Score on the ABILHAND-Kids Questionnaire [Срок оценки: Baseline (single assessment session)]
• Number of Blocks Transferred in Sixty Seconds During the Box and Block Test [Срок оценки: Baseline (single assessment session)]
• Classification Level on the Gross Motor Function Classification System [Срок оценки: Baseline (single assessment session)]
• Mean Hand Grip Strength of the Affected Hand Measured With a Hand Dynamometer [Срок оценки: Baseline (single assessment session)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07394439 · Acetinkaya009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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