Impacts of Two Rehabilitation Programs on Chronic Peripheral Facial Paresis (VISAGE)

Clinical, Kinematic and Quality-of-life Related Impacts of Two Rehabilitation Programs in Chronic Peripheral Facial Paresis: a Randomized Control Trial.

Introduction: Peripheral facial paresis (PFP) is a very common disease of various etiologies affecting average adults with no predominance of sex. In 70% of cases, motor recovery is rapid and complete, but in 30% of early PFP, motor symptoms such as paresis and/or abnormal movements (synkinesis, contractures and/or spasms) can live on and jeopardize patients quality of life at medium and even long term. Concerning therapeutic interventions, the rehabilitation patient care of PFP is often restricted to the early stage. A recent randomized controlled study showed that early rehabilitation had a positive impact on motor recovery, specifically in severe motor grades, and could also accelerate time of recovery without exacerbating synkinesis. At chronic stage of the pathology, there is no controlled study testing the effect of motor rehabilitation when deficiencies are often considered as fitted and permanents.

Objective: It is well known in other domains that intensive motor strengthening increases cerebral plasticity in general, and particularly that of sensorimotor command. The main hypothesis of the study is that motor strengthening even at chronic stage of PFP could increase motor function and decrease abnormal motor movements through a self-rehabilitation motor program. The main objective is thus to compare the clinical, kinematic and quality-of-life related impacts of two different rehabilitation programs on motor recovery in unilateral PFP at chronic stage (i.e. at least 1 year after injury): a self-rehabilitation program guided by Physical Medicine and Rehabilitation (PMR) therapist versus facial rehabilitation involving physiotherapist or speech therapist specialized in facial rehabilitation. The main evaluation criterion is the evolution of the Sunnybrook Facial Grading Scale composite score between Day0 (before rehabilitation) and Day180 (after 6 months of facial rehabilitation).

Method: National, Randomized simple blind controlled study, in two parallel groups: Both program have to be realized daily for 6 months (Day1 to Day180). The population is made of adults with unilateral PFP at chronic stage i.e. at least 1 year from injury. Evaluations and follow-up of patients will be accomplished in a single center: Service de Rééducation Neurolocomotrice de l'Hôpital Mondor in Créteil (France).

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Facial Palsy; Motor Recovery; Self-rehabilitation
• Intervention / Treatment: Other: Self-rehabilitation program; Other: Conventional rehabilitation program

• Study Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marjolaine BAUDE, MD; Phone Number: +0033 1 49 81 30 61; Email: marjolaine.baude@aphp.fr

Study Locations

• France
  • Paris, France, 75014
    • Not yet recruiting
    • Hôpital Saint-Joseph
    • Contact: Ludovic BENICHOU, MD
  • Val De Marne
    • Créteil, Val De Marne, France, 94010
      • Recruiting
      • Centre Hospitalier Intercommunal de Créteil
      • Contact: André COSTE, MD-PhD; Email: andre.coste@chicreteil.fr
    • Créteil, Val De Marne, France, 94010
      • Recruiting
      • Hôpital Henri Mondor
      • Contact: Marjolaine BAUDE, MD; Email: marjolaine.baude@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 17 yo;
• Ambulatory patient;
• Motivation to participate to a rehabilitative facial program for six months;
• Patient consent to shaving (men) and no makeup (women) in order not to hamper evaluations the morning of the 4 visits of the study ;
• Signed informed consent;
• Affiliation to asocial security scheme.

Exclusion Criteria:

• Peripheral facial paresis of evolving tumoral etiology;
• Medical history of botulinum toxin injections in facial muscles during the last 6 months preceding inclusion or injections planned during the study;
• Medical history of facial surgery in the last two years preceding inclusion or planned during the study;
• Medical history of facial reanimation surgery needing specific rehabilitation (V-VII or XII-VII anastomosis or muscle transfer);
• Medical history of medical aesthetic facial treatments (hyaluronic acid/ lipofilling/laser/bracing wires) in the preceding two years before inclusion or planned during the study;
• Recurrent PFP;
• Implication in other research interventional protocol dealing with aesthetical aspect of the face or with PFP;
• Intercurrent pathology impeding the realization of the rehabilitation program during the study;
• Cognitive, mental or psychiatric troubles impeding the realization of the rehabilitation program or the capacity to attend both evaluations and follow-up consultations;
• Tutorship or guardianship patient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Self-rehabilitation guided program with investigator PMR specialist	Other: Self-rehabilitation program; facial self-rehabilitation for a duration of 6 months
Active Comparator: Control group; Conventional rehabilitation with a speech therapist or physiotherapist specialized in facial rehabilitation	Other: Conventional rehabilitation program; Conventional facial rehabilitation for a duration of 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Composite score of the Sunnybook Facial Grading System	estimation of resting symmetry (score 0 to 20), symmetry at voluntary movement (score 20 to 100) and synkinesis (score 0 to 15) composite score = symmetry at voluntary movement - resting symmetry - synkinesis from Day 0 to Day 180. (Ross et al. 1996, PMID: 8649870)	Day 0 and Day 180

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Marjolaine BAUDE, MD, APHP CHU Henri Mondor

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: August 28, 2019
• First Posted (Actual): August 29, 2019

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; Paralysis; Paresis; Facial Paralysis; Facies
• Other Study ID Numbers: K170105J

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