Cerebral Palsy Clinical Trial
Official title:
A Pilot Study to Assess the Efficacy and Effectiveness of High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations in Children With Muscle Weakness and Restrictive Lung Disease CR-0088
To asssess efficacy of airway clearance provided by Vest therapy (HFCWO) in the reduction of respiratory exacerbations requiring hospitalization or antibiotic utilization in patients with muscle weakness and restrictive lung disease.
This non-randomized home based pre-post intervention study. The study will compare the
efficacy of Vest® therapy (HFCWO) for mucus secretion clearance in a population of patients
with muscle weakness and restrictive lung disease with frequent pulmonary exacerbations.
Enrolled subjects with a tracheostomy will be evaluated for microbial load and inflammatory
status as a pilot evaluation of microbial load and inflammatory status outcomes.
The total number of evaluable subjects to be recruited is estimated at 40. Subjects will be
considered evaluable if they have completed at least 6 months of follow up.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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