Assessing Fatiguability of Tongue Muscles in MS

NCT ID: NCT03817073

Last Updated: 2019-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-07-01

Brief Summary

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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

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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

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Muscle Weakness Fatigue Multiple Sclerosis Deglutition Disorders Exertion; Excess

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Iowa Oral Performance Instrument (IOPI)

Intervention Type DEVICE

Using biofeedback to attain repetitions of 80% of baseline MIP.

Interventions

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Iowa Oral Performance Instrument (IOPI)

Using biofeedback to attain repetitions of 80% of baseline MIP.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* proven MS
* subjective dysphagia

Exclusion Criteria

* MMSE \< 23
* major head and neck surgery
* history of cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Revalidatie & MS Centrum Overpelt

OTHER

Sponsor Role collaborator

Thomas More Kempen

OTHER

Sponsor Role lead

Responsible Party

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Jan Vanderwegen

Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Vanderwegen

Role: PRINCIPAL_INVESTIGATOR

Thomas More University College

Locations

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Thomas More University College of Applied Sciences

Antwerp, Antwerpen, Belgium

Site Status

Countries

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Belgium

Central Contacts

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Jan Vanderwegen, MD

Role: CONTACT

03 241 08 29

Facility Contacts

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JAN VANDERWEGEN, MD

Role: primary

+32 3 241 08 29

Other Identifiers

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TMALA19JVDW01

Identifier Type: -

Identifier Source: org_study_id

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