Status:
COMPLETED
Bio-feedback Treatment for Dysphagic Post-stroke Patients
Lead Sponsor:
IRCCS San Camillo, Venezia, Italy
Conditions:
Dysphagia, Late Effect of Stroke
Deglutition Disorders
Eligibility:
All Genders
18-81 years
Phase:
NA
Brief Summary
The primary purpose of the study is to evaluate whether the effect of bio-feedback dysphagia treatment is more effective than a control treatment in post-stroke patients. This study will be a randomi...
Detailed Description
The procedure is divided into 5 parts: * Clinical and instrumental evaluation (fibroendoscopy) of swallowing functions before the treatment; * 25 sessions with bio feedback treatment or 25 sessions o...
Eligibility Criteria
Inclusion
- first stroke injury
- single lesion
- onset from more than six weeks
- presence of dysphagia (Dysphagia Outcome and Severity Scale ≥ 4)
- good comprehension ( not below PT 53 in Token Test)
- good eyesight and hearing, or adequately corrected
Exclusion
- All the elements that hinder a good recording of the electromyographic signal (for instance a cutaneous infection, a wound or a dermatitis in the submandibular area);
- Severe concomitant illnesses (fever, infections, metabolic problems, serious cardiac insufficiency) that can influence patient's collaboration;
- Serious dystonia or unintentional movements
- presence of disorders of consciousness;
- encephalopathy due to multiple infarcts;
- inability to sustain the experimental treatment;
- other neurological diseases (for example Parkinson disease);
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2022
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03247374
Start Date
February 27 2018
End Date
October 4 2022
Last Update
October 5 2022
Active Locations (1)
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1
Sara Nordio
Venice-Lido, Italy