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Behavioural Intervention
Respiratory Training for Friedreich's Ataxia
N/A
Recruiting
Led By Carmen Leon Astudillo, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* confirmed genetic testing of Friedreich's Ataxia
* are able to perform pulmonary function testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (4 months)
Awards & highlights
No Placebo-Only Group
Summary
This trial will study patients with Friedreich's Ataxia who will undergo respiratory strength training for 12 weeks. The study will have two research visits - one at the beginning and one at the end
Who is the study for?
This trial is for individuals who can perform pulmonary function tests, have genetically confirmed Friedreich's Ataxia, and show a certain level of swallowing difficulty. It's not specified who cannot join the trial.
What is being tested?
The study examines the effects of Respiratory Strength Training (RST) on patients with Friedreich's Ataxia over 12 weeks. Participants will undergo evaluations including swallowing assessments, lung function tests, muscle activity measurements, and surveys before and after training.
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include discomfort from exercises or fatigue due to increased respiratory effort during RST.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My genetic test confirmed I have Friedreich's Ataxia.
Select...
I can do lung function tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion (4 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (4 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Diaphragm Ultrasound
Force Vital Capacity
Maximal Expiratory Pressure (MEP)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Respiratory Strength Training (RST)Experimental Treatment1 Intervention
Participants will receive a respiratory strength training device to take home and use up to 5 times a week for 12 weeks.
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,409 Previous Clinical Trials
767,545 Total Patients Enrolled
4 Trials studying Friedreich Ataxia
621 Patients Enrolled for Friedreich Ataxia
Carmen Leon Astudillo, MDPrincipal InvestigatorUniversity of Florida