An interventional study of Iowa Oral Performance Instrument (IOPI) in Muscle Weakness, Fatigue and Multiple Sclerosis, sponsored by Thomas More Kempen. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-25.
Sponsored by Thomas More Kempen · Not applicable, Interventional, and Screening
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.
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.
601 studies on the registry are indexed under Muscle Weakness; 99 are open to participants now.
This study's planned enrollment of 60 is above the median of 46 across 444 interventional studies indexed under Muscle Weakness.
Browse Muscle Weakness studies →Thomas More Kempen is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
The number of repetitions where the target force was developed.
Time frame: 30 minutes
Evolution of MIP during subsequent repetitions
The change in MIP after each 5 repetitions.
Time frame: 30 minutes
Baseline MIP as predictor for number of repetitions
Does baseline MIP predict the number of successful repetitions.
Time frame: 30 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Thomas More Kempen