Validation of a French-language Version of Quality of Life Questionnaires in Patients With Peripheral Facial Palsy

NCT03581253 | Unknown

• 1 other identifier: 2017-44
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Facial palsy is a serious and disabling disease whose drudgery and sensation are probably underestimated. Psychological, social and economic issues have major impacts although vital prognosis is not engaged in this pathology. Facial palsy remains a personal drama for patient. Consequences may take the form of: aesthetic deformation, modification of body image, with socio-professional consequences. Beside unsightly facial aspects, weakness of facial muscles can cause troubles in eating, drinking, talking, communicating personal emotions and communication. Facial palsy impacts patients' quality of life (QOL) and affects mental health. This wide multidimensional concept usually includes self-measures of physical and mental health. QOL is evaluated with general and specific scales. General scales allow to compare QOL of different diseases, when specific scales focus on one disease and consider all aspects related to this disease and therefore are more appropriate and sensitive in dimensions related to patient disease and health. "Facial disability Index" (FDi) and "Facial Clinimetric Evaluation" (FaCE) are the most used validated questionnaires to assess QOL of patients suffering from peripheral facial palsy (PFP). There is no existing validated questionnaire or scale in French version despite many French studies on PFP available. Using these questionnaires in French language requires translation and strict approval of the new language version. The aim of the study is to translate and validate French versions of specific scales of QOL in peripheral facial palsy patients: FDI and FaCE. Secondary objective is to evaluate QOL of patients depending on PFP etiology. Translation process will be done respecting internationally recognized rules. A pilot study will be performed on 5 physicians and 5 patients in order to validate the questionnaires translations. French versions obtained will be used for their validation on 80 patients suffering from PFP. Cronbach's alpha will be estimated to check internal consistency of FDI and FaCE scales. Test re-test reliability will be calculated with inter-class correlation, reiterating questionnaires one week later. Scores of FDI and FaCE scales will be compared to other clinical evaluation scales, estimating correlation coefficient. Social function of FDI and FaCE scales will be compared with general scale SF-36 scores, estimating a correlation coefficient.

Conditions

Peripheral Facial Paralysis; Quality of Life

Outcome Measures

Primary Outcomes (1)

• "Facial disability Index" (FDi)

  questionnaire to assess the oral, ocular and the influence of facial impairment on emotions and daily activity

  one week

Secondary Outcomes (4)

• Facial Clinimetric Evaluation" (FaCE)

  one week

• House-Brackmann score

  one week

• Sunnybrook index

  one week

• SF-36 score

  one week

Study Arms (1)

peripheral facial palsy patients

EXPERIMENTAL

peripheral facial palsy patients will performed questionnaires of quality of life ("Facial disability Index" (FDi) and "Facial Clinimetric Evaluation" (FaCE)

Other: Facial disability Index" (FDi); Other: "Facial Clinimetric Evaluation" (FaCE)

Interventions

Facial disability Index" (FDi) OTHER

questionnaires regarding to quality of life

peripheral facial palsy patients

"Facial Clinimetric Evaluation" (FaCE) OTHER

questionnaires regarding to quality of life

peripheral facial palsy patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with peripheral facial palsy
• Age over 18 years old.
• Subject wishing and able to give informed consent and to respect the requirements of the protocol

You may not qualify if:

• Patient not being French.
• Patient who can not read French.
• Facial graduation.
• Facial dysfunction other than PFP such as facial trauma.
• Major medical or psychiatric illness that, in the opinion of the investigator, would pose a risk to the subject or could compromise compliance with the study protocol.
• Legal incapacity or limited legal capacity.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13005, France

RECRUITING

MeSH Terms

Conditions

Facial Paralysis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• EMILIE GARRIDO PRADALIE

  ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE

  STUDY DIRECTOR

Central Study Contacts

MARION MONTAVA, MD

CONTACT

+33491435618; Marion.MONTAVA@ap-hm.fr

CECILE LAVOUTE, PHD

CONTACT

+33491381878; cecile.lavoute@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 10, 2018
• Study Start: December 15, 2017
• Primary Completion: December 15, 2018
• Study Completion: June 1, 2019
• Last Updated: July 12, 2018

Record last verified: 2018-06

Locations

FR (1)