Assessing Fatiguability of Tongue Muscles in MS
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2019
CompletedFirst Posted
Study publicly available on registry
January 25, 2019
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedJanuary 25, 2019
January 1, 2019
2.3 years
January 8, 2019
January 24, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Number of successful repetitions
The number of repetitions where the target force was developed.
30 minutes
Evolution of MIP during subsequent repetitions
The change in MIP after each 5 repetitions.
30 minutes
Secondary Outcomes (1)
Baseline MIP as predictor for number of repetitions
30 minutes
Study Arms (1)
Iowa Oral Performance Instrument (IOPI)
EXPERIMENTALAll MS patients will be included in this arm to compare with a historical control arm. Iowa Oral Performance Instrument (IOPI).
Interventions
Using biofeedback to attain repetitions of 80% of baseline MIP.
Eligibility Criteria
You may qualify if:
- proven MS
- subjective dysphagia
You may not qualify if:
- MMSE \< 23
- major head and neck surgery
- history of cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomas More Kempenlead
- Revalidatie & MS Centrum Overpeltcollaborator
Study Sites (1)
Thomas More University College of Applied Sciences
Antwerp, Antwerpen, 2018, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Vanderwegen
Thomas More University College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
January 8, 2019
First Posted
January 25, 2019
Study Start
March 1, 2019
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
January 25, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share