Effect of gum-based bolus viscosities on the safety of swallowing in patients with chronic post-stroke oropharyngeal dysphagia
- Conditions
- Dysphagia
- Registration Number
- NL-OMON25638
- Lead Sponsor
- utricia Research BV
- Brief Summary
n/a
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
1.Diagnosis of stroke, and minimum 28 days since stroke
2.Clinical signs or symptoms of swallowing dysfunction, based on Eating Assessment Tool (EAT-10) questionnaire, or bedside clinical test or water swallow test, or referral by medical doctor for Video FluoroScopy (VFS)-test, or current use of thickened products
Exclusion Criteria
1.Patients with respiratory insufficiency in need of additional oxygen
2.Dysphagia not related to stroke
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of subjects that swallow viscosity levels 1, 2 and 3 safely (PAS score 1,2) compared to thin iodine liquid control
- Secondary Outcome Measures
Name Time Method •Safety of swallowing per individual viscosity as measured by:<br /><br>•Percentage of subjects that swallow safely (PAS score 1,2)<br /><br>•Percentage of subjects with penetration (PAS score 3,4,5)<br /><br>•Percentage of subjects with aspiration (PAS score 6,7,8)<br /><br>•Mean PAS score<br /><br>•Efficacy of swallowing per individual viscosity as expressed by:<br /><br>•Presence and severity of oral residue (score 0,1,2) Presence and severity of pharyngeal residue (score 0,1,2)