Actively Recruiting
Efficacy of EFA in Acquired Brain Injury
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2024-08-09
20
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of EFA in Acquired Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age higher than 18 years old
- Hospitalized after diagnosis of Acquired Brain Injury (traumatic or vascular)
- Levels of Cognitive Functioning Scale (LCFS) score between 1 and 5
- Presence of spontaneous breathing at least during the day
You will not qualify if you...
- Need of mechanical ventilation for more than 12 hours a day
- Presence of tracheal stoma not properly healed after removal of the tracheal cannula
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Don Carlo Gnocchi - Centro Ettore Spalenza
Rovato, BS, Italy, 25038
Actively Recruiting
Research Team
R
Riccardo NC Buraschi, PT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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