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NCT07873593
The Effects of Protocolized Breathing Exercises on Pulmonary Function in Adolescents With Cerebral Palsy.
Conditions: Cerebral Palsy
Sex: All
Ages: 12 Years – 22 Years
Healthy volunteers: No
Phase: NA
Enrollment: 360
Sponsor: Semmelweis University
Location: Semmelweis University András Pető Faculty Budapest Pest County
Summary
This multicenter randomized controlled pilot trial evaluates whether an 8-week protocolized breathing exercise program improves pulmonary function and quality of life in adolescents and young adults with cerebral palsy. Participants are randomized to either a structured breathing exercise program added to usual pedagogical rehabilitation care or sham breathing exercises plus usual care.
The study assesses changes in spirometric outcomes (FVC, FEV₁, PEF) and patient-reported quality of life and emotional well-being. Participants complete respiratory assessments and questionnaires at baseline, post-intervention, and follow-up.
Eligibility Criteria
Inclusion Criteria
1. Children and young adults with a diagnosis of CP
2. GMFCS Levels I to V
3. Ages ≥12 to ≤22 years
4. Ability to perform spirometry
5. Ability to follow instructions
6. Informed consent signed by legal guardian
Exclusion Criteria
1. Use of respiratory support in the past 12 months
2. Botulinum toxin injections within 12 months prior to enrolment
Source: ClinicalTrials.gov (NCT07873593). StuddyBuddy aggregates publicly available trial information.