Assessing Fatiguability of Tongue Muscles in MS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03817073|
Recruitment Status : Not yet recruiting
First Posted : January 25, 2019
Last Update Posted : January 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Muscle Weakness Fatigue Multiple Sclerosis Deglutition Disorders Exertion; Excess||Device: Iowa Oral Performance Instrument (IOPI)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessing Fatiguability of Tongue Muscles and the Effect on Tongue Strength and Swallowing Pressures in Patients With Multiple Sclerosis|
|Estimated Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||July 1, 2021|
Experimental: Iowa Oral Performance Instrument (IOPI)
All MS patients will be included in this arm to compare with a historical control arm. Iowa Oral Performance Instrument (IOPI).
Device: Iowa Oral Performance Instrument (IOPI)
Using biofeedback to attain repetitions of 80% of baseline MIP.
- Number of successful repetitions [ Time Frame: 30 minutes ]The number of repetitions where the target force was developed.
- Evolution of MIP during subsequent repetitions [ Time Frame: 30 minutes ]The change in MIP after each 5 repetitions.
- Baseline MIP as predictor for number of repetitions [ Time Frame: 30 minutes ]Does baseline MIP predict the number of successful repetitions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817073
|Contact: Jan Vanderwegen, MD||03 241 08 email@example.com|
|Thomas More University College of Applied Sciences|
|Antwerp, Antwerpen, Belgium, 2018|
|Contact: JAN VANDERWEGEN, MD +32 3 241 08 29 firstname.lastname@example.org|
|Principal Investigator:||Jan Vanderwegen||Thomas More University College|