Efficacy of EFA in Acquired Brain Injury

Acquired brain injury (ABI) is one of the biggest cause of death and disability in the world. Patients with ABI often have difficulties with swallow and breath. The study purpose is to evaluate if the Expiratory Flow Accelerator (EFA) technology has positive effects on the respiratory and swallowing function in patients with acquired brain injury (ABI). Researchers recruit patients at Centro Ettore Spalenza-Fondazione Don Carlo Gnocchi in Rovato, Italy. To partecipate, patients should satisfy certain eligibility criteria; they will not be enrolled if they satisfy exclusion criteria. If a patient can be recruited, researchers conduct the baseline assessment lasting 1 one week. After that, the patient will be randomized to the study or control group. If the patient is in the control group, he will receive a traditional rehabilitation treatment. Otherwise, the patient will receive an additional treatment with the EFA device. Researchers will assess again the patient (with the same procedures of baseline assessment) after 8 weeks of treatment. They want to see if the EFA device could help patients with ABI to improve their health conditions.

NCT Number	NCT05993364
Lead Sponsor	Fondazione Don Carlo Gnocchi ETS
Conditions	Acquired Brain Injury, Comparative Effectiveness Research, Lung Diseases, Obstructive
Enrollment	20 participants
Start Date	2024-02-19
Primary Completion	2025-02 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2024-08-09