Impacts of Two Rehabilitation Programs on Chronic Peripheral Facial Paresis

NCT ID: NCT04074018

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2023-06-30

Brief Summary

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).

Conditions

Facial Palsy; Self-rehabilitation; Quality of Life; Motor Recovery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group

Self-rehabilitation guided program with investigator PMR specialist

Group Type: EXPERIMENTAL

Self-rehabilitation program

Intervention Type: OTHER

facial self-rehabilitation for a duration of 6 months

Control group

Conventional rehabilitation with a speech therapist or physiotherapist specialized in facial rehabilitation

Group Type: ACTIVE_COMPARATOR

Conventional rehabilitation program

Intervention Type: OTHER

Conventional facial rehabilitation for a duration of 6 months

Interventions

Self-rehabilitation program

facial self-rehabilitation for a duration of 6 months

Intervention Type: OTHER

Conventional rehabilitation program

Conventional facial rehabilitation for a duration of 6 months

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marjolaine BAUDE, MD

Role: PRINCIPAL_INVESTIGATOR

APHP CHU HENRI MONDOR

Locations

Centre Hospitalier Intercommunal de Créteil

Créteil, Val De Marne, France

Site Status: RECRUITING

Hôpital Henri Mondor

Créteil, Val De Marne, France

Site Status: RECRUITING

Hôpital Saint-Joseph

Paris, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Marjolaine BAUDE, MD

Role: CONTACT

marjolaine.baude@aphp.fr

+0033 1 49 81 30 61

Facility Contacts

André COSTE, MD-PhD

Role: primary

andre.coste@chicreteil.fr

Marjolaine BAUDE, MD

Role: primary

marjolaine.baude@aphp.fr

Ludovic BENICHOU, MD

Role: primary

References

Baude M, Guihard M, Gault-Colas C, Benichou L, Coste A, Meningaud JP, Schmitz D, Natella PA, Audureau E, Gracies JM. Guided Self-rehabilitation Contract vs conventional therapy in chronic peripheral facial paresis: VISAGE, a multicenter randomized controlled trial. BMC Neurol. 2023 Apr 10;23(1):148. doi: 10.1186/s12883-023-03096-8.

Reference Type: DERIVED

PMID: 37038105 (View on PubMed)

Other Identifiers

K170105J

Identifier Type: -

Identifier Source: org_study_id