Facial PalsyVISAGENCT04074018
Impacts of Two Rehabilitation Programs on Chronic Peripheral Facial Paresis
A study testing Self-rehabilitation program and Conventional rehabilitation program in people with Facial Palsy and Self-rehabilitation, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Palsy, Self-rehabilitation, Quality of Life
- What is being tested?
- Self-rehabilitation program and Conventional rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 3 sitesFrance
- Study dates
- 4 Jan 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Centre Hospitalier Intercommunal de Créteil
Créteil, Val De Marne, 94010
André COSTE, MD-PhD, andre.coste@chicreteil.fr
- Recruiting
Hôpital Henri Mondor
Créteil, Val De Marne, 94010
Marjolaine BAUDE, MD, marjolaine.baude@aphp.fr
- Not yet recruiting
Hôpital Saint-Joseph
Paris, 75014
Ludovic BENICHOU, MD
About this study
Official title: 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).
- Conditions
- Facial Palsy, Self-rehabilitation, Quality of Life, Motor Recovery
- Being tested
- Self-rehabilitation program, Conventional rehabilitation program
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-rehabilitation programOther
facial self-rehabilitation for a duration of 6 months
Conventional rehabilitation programOther
Conventional facial rehabilitation for a duration of 6 months
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Self-rehabilitation guided program with investigator PMR specialist Receives: Other: Self-rehabilitation program |
| Control group | Active comparator | Conventional rehabilitation with a speech therapist or physiotherapist specialized in facial rehabilitation Receives: Other: Conventional rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 0 and Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start4 Jan 2021
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facial PalsyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups, using computerized randomization, for the duration of the study in each center.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjolaine BAUDE, MD, Principal investigator, APHP CHU HENRI MONDOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074018
- Sponsor's protocol ID
- K170105J
- Acronym
- VISAGE
- Status last verified
- Jun 2022
- First submitted
- 23 Jul 2019
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37038105
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Kinematic and Quality-of-life Related Impacts of Two Rehabilitation Programs in Chronic Peripheral Facial Paresis: a Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT04074018
- Acronym / sponsor ID
- VISAGE / K170105J
- Conditions
- Facial Palsy, Self-rehabilitation, Quality of Life, Motor Recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 29 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups, using computerized randomization, for the duration of the study in each center.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Self-rehabilitation programSelf-rehabilitation guided program with investigator PMR specialist |
| Control group | Active comparator | Other: Conventional rehabilitation programConventional rehabilitation with a speech therapist or physiotherapist specialized in facial rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-rehabilitation programfacial self-rehabilitation for a duration of 6 months | Other | Experimental group |
| Conventional rehabilitation programConventional facial rehabilitation for a duration of 6 months | Other | Control group |
Primary outcome
Change of Composite score of the Sunnybook Facial Grading System
Time frame: Day 0 and Day 180
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Derived from this study: PubMed 37038105Baude 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjolaine BAUDE, MD principal investigator
APHP CHU HENRI MONDOR
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-rehabilitation program and Conventional rehabilitation program in people with Facial Palsy and Self-rehabilitation, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marjolaine BAUDE, MD (+0033 1 49 81 30 61, marjolaine.baude@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Composite score of the Sunnybook Facial Grading System (time frame: Day 0 and Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04074018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.