Trials / Unknown
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
| Type | Name | Description |
|---|---|---|
| DEVICE | Iowa 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.