Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03284125
Other study ID # RIPH3-RNI17/MATPF
Secondary ID 2017-A01577-4620
Status Completed
Phase
First received
Last updated
Start date September 2, 2017
Est. completion date June 12, 2018

Study information

Verified date April 2021
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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 .


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date June 12, 2018
Est. primary completion date June 12, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Years and older
Eligibility 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 Design


Intervention

Other:
Swallowing disorders evaluation
Self-administered questionnaires and non-invasive clinics tests

Locations

Country Name City State
France Service de chirurgie maxillo-faciale, CHRU de TOURS Tours

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT06393231 - Clinical Study on the End Time of Acupuncture and Moxibustion Therapy for Peripheral Facial Paralysis N/A
Completed NCT00903669 - Anthropometric Angular Measurement to Determine Muscle Tonus in Patients With Peripheral Facial Paralysis N/A
Recruiting NCT05191719 - Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy N/A
Recruiting NCT03581253 - Validation of a French-language Version of Quality of Life Questionnaires in Patients With Peripheral Facial Palsy N/A