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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Self-rehabilitation guided program with investigator PMR specialist |
|
| Control group | Active Comparator | Conventional rehabilitation with a speech therapist or physiotherapist specialized in facial rehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-rehabilitation program | Other | facial self-rehabilitation for a duration of 6 months |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marjolaine BAUDE, MD | Contact | +0033 1 49 81 30 61 | marjolaine.baude@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marjolaine BAUDE, MD | APHP CHU HENRI MONDOR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Intercommunal de Créteil | Recruiting | Créteil | Val De Marne | 94010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37038105 | Derived | 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. |
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| ID | Term |
|---|---|
| D005158 | Facial Paralysis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
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Participants are assigned to one of two groups, using computerized randomization, for the duration of the study in each center.
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| Conventional rehabilitation program | Other | Conventional facial rehabilitation for a duration of 6 months |
|
| Hôpital Henri Mondor | Recruiting | Créteil | Val De Marne | 94010 | France |
|
| Hôpital Saint-Joseph | Not yet recruiting | Paris | 75014 | France |
|
| D009422 |
| Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |