Impacts of Two Rehabilitation Programs on Chronic Peripheral Facial Paresis

NCT04074018 | Unknown

• 1 other identifier: K170105J
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

Self-rehabilitation guided program with investigator PMR specialist

Other: Self-rehabilitation program

Control group

ACTIVE COMPARATOR

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

Other: Conventional rehabilitation program

Interventions

Self-rehabilitation program OTHER

facial self-rehabilitation for a duration of 6 months

Experimental group

Conventional rehabilitation program OTHER

Conventional facial rehabilitation for a duration of 6 months

Control group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Peripheral facial paresis of evolving tumoral etiology;
• Medical history of facial reanimation surgery needing specific rehabilitation (V-VII or XII-VII anastomosis or muscle transfer);
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

Centre Hospitalier Intercommunal de Créteil

Créteil, Val De Marne, 94010, France

RECRUITING

Hôpital Henri Mondor

Créteil, Val De Marne, 94010, France

RECRUITING

Hôpital Saint-Joseph

Paris, 75014, France

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 37038105 DERIVED

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

• Marjolaine BAUDE, MD

  APHP CHU HENRI MONDOR

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marjolaine BAUDE, MD

CONTACT

+0033 1 49 81 30 61; marjolaine.baude@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two groups, using computerized randomization, for the duration of the study in each center.

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: August 29, 2019
• Study Start: January 4, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)