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UnknownNCT03817073

Assessing Fatiguability of Tongue Muscles in MS

Assessing Fatiguability of Tongue Muscles and the Effect on Tongue Strength and Swallowing Pressures in Patients With Multiple Sclerosis

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Thomas More Kempen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Multiple Sclerosis (MS) patients with subjective dysphagia will be tested for tongue strength fatigue using a strictly defined fatigue paradigm. A maximum of 40 sets will be performed, each set consisting of 5 repetitions of 80% of maximum isometric pressure (MIP) at the anterior tongue, followed by a MIP at the anterior tongue. Cut-off criteria are a MIP \<50% of the baseline MIP, pronounced subjective discomfort and/or exceeding the allocated test time of 30 minutes.

Detailed description

Eligibility is Mini-Mental State Exam-score (MMSE) \> 23, a Eating Assessment Tool-score (EAT-10) \> 3, or a Functional Oral Intake Scale-score (FOIS) \< 7, or failing the Yale Swallow Protocol.

Conditions

Interventions

TypeNameDescription
DEVICEIowa Oral Performance Instrument (IOPI)Using biofeedback to attain repetitions of 80% of baseline MIP.

Timeline

Start date
2019-03-01
Primary completion
2021-07-01
Completion
2021-07-01
First posted
2019-01-25
Last updated
2019-01-25

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03817073. Inclusion in this directory is not an endorsement.

Assessing Fatiguability of Tongue Muscles in MS (NCT03817073) · Clinical Trials Directory