Lengthening Temporalis Myoplasty and Improvement of Primary Swallowing Disorders in Facial Paralysis

Study Overview
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Brief Summary
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The facial paralysis is a frequent disease causing important functionals swallowing dysfunctions. The purpose of our study was to evaluate the improvement of the swallowing disorders after surgery by lengthening temporalis myoplasty (LTM) in the facial paralysis. This prospective study has realised on the following of patients affected by facial paralysis treated by LTM. Self-administered questionnaires and clinics tests had realized to analyze three components oh the oral phase of the swallowing ( drooling, mastication and handicap). The evaluations was realized before the surgery and at 3 and 6 months after .

Official Title
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Lengthening Temporalis Myoplasty and Improvement of Primary Swallowing Disorders in Facial Paralysis

Conditions
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Peripheral Facial Paralysis

Intervention / Treatment
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* Other: Swallowing disorders evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic peripheral facial paralysis Freyss score inferior at 15 Benefiting of a lengthening temporalis myoplasty Exclusion Criteria: Malformative syndrome Other swallowing trouble Psychiatric trouble Opposed at this study

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Facial paralysis<br>Patients affected by facial paralysis treated by LTM The aim is to evaluate the improvement of the swallowing disorders after surgery. | Other: Swallowing disorders evaluation<br>* Self-administered questionnaires and non-invasive clinics tests<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline lips pressure at 6 months | Patients must contracted their lips of the paretic side in a manometer to evaluate the pressure of the lips before surgery and at 3 and 6 months after | Baseline, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drooling Severity and Frequency Scale (DSFS) | The Drooling Score equals the sum of the Severity and Frequency sub-scores. the severity sub scores contains five items ( 1= never, 2= mild drooling, 3= moderate drool, 4= severe drool, 5= profuse drool) The frequency sub score contains four items ( 1= no drooling, 2= occasionally, 3=frequently, 4= constant drooling) | Baseline, 3 and 6 months | 
| Visual scale of food residue | Patients must eat a melba toast on paretic side and after we evaluate the food residue before surgery and at 3 and 6 months after | Baseline, 3 and 6 months | 
| Dysphagia handicap index (DHI) | This self-administered questionnaire allows to evaluate 3 types of handicap (physical, functional and social) It contains 30 questions and the maximum score is 120 (0= never, 1= almost never, 2= occasionally, 3= almost always, 4= always) | Baseline, 3 and 6 months |