Informations générales (source: ClinicalTrials.gov)
Clinical, Kinematic and Quality-of-life Related Impacts of Two Rehabilitation Programs in Chronic Peripheral Facial Paresis: a Randomized Control Trial. (VISAGE)
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
janvier 2021
juin 2023
19 octobre 2024
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | BAUDE Marjolaine | 12/04/2024 09:28:26 | Contacter | ||
| CHI DE CRETEIL | André COSTE | 29/03/2024 01:29:43 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| GH PARIS SITE SAINT JOSEPH | Ludovic BENICHOU, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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.