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

April 27, 2021 updated by: University Hospital, Tours

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37044
        • Service de chirurgie maxillo-faciale, CHRU de TOURS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients affected by facial paralysis and treated by lenthening temporalis myoplasty

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Facial paralysis
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
Self-administered questionnaires and non-invasive clinics tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline lips pressure at 6 months
Time Frame: Baseline, 3 and 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)
Time Frame: Baseline, 3 and 6 months
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
Time Frame: Baseline, 3 and 6 months
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)
Time Frame: Baseline, 3 and 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Boris LAURE, MD-PhD, University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2017

Primary Completion (Actual)

June 12, 2018

Study Completion (Actual)

June 12, 2018

Study Registration Dates

First Submitted

September 6, 2017

First Submitted That Met QC Criteria

September 12, 2017

First Posted (Actual)

September 15, 2017

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPH3-RNI17/MATPF
  • 2017-A01577-46 (Other Identifier: IdRCB)
  • 2017-39 (CPP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peripheral Facial Paralysis

Clinical Trials on Swallowing disorders evaluation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe