Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02892864 |
| Other study ID # |
P131203 |
| Secondary ID |
2015-A01428-41 |
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 24, 2017 |
| Est. completion date |
March 7, 2018 |
Study information
| Verified date |
May 2019 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Facial palsy can be divided into supranuclear lesion (central facial palsy) and infranuclear
lesion such as Bell's Palsy, an idiopathic disease. The peripheral facial paralysis (PFP) is
a frequent but little-known pathology (20 / 100 000 inhabitants in France a year). Oro-facial
functions and the ability to convey emotional facial information are seriously affected by
facial palsy, thereby reducing patient's quality of life. The PFP can have several
repercussions on the functional, aesthetic, social, occupational and psychological levels.
Evolution and prognosis depend not only on its etiology and gravity, but also on the
precocity and the quality of the medical and paramedical care. It is essential to assess
functional and psychological issues before beginning an adapted global therapeutic care. If
these depressive symptoms can be explained by multiple factors, the inability to smile would
be one of the triggering factors of depression. The facial feedback hypothesis could be one
of many explications because smiling induces a positive emotional state and a feeling of
well-being. In PFP, patients must cope with their difficulties to smile. Their facial
behaviour affected their own emotional experiences.
The main purpose of the present study is to determine if virtual rehabilitation program is
relevant compared to standard therapy. The second aim is to characterize the efficiency by
analysing the time required to obtain a stable score of 4 in the Sunnybrook test. A secondary
objective will be to decrease the functional and social repercussions of the facial paralysis
with an intensive and targeted therapy of the smile. Furthermore, a virtual rehabilitation
program will be implemented in an interactive platform.
To this end, a parallel randomized controlled trial (RCT) of the two groups will be
conducted: standard therapy versus virtual rehabilitation program. RCT involves a treatment
in which active participation of the patient is necessary so only the assessment will be
blinded. Facial motor skills (tongue, mouth and face motricity) are measured using electronic
devices, objective and subjective evaluation with pragmatic fields such as communication,
emotion and quality of life. The severity of patient's facial paralysis is appraised by the
House and Brackmann scale. This global assessment will be conducted before the beginning of
the therapy and every 3 months during 18 months.
The patients will be recruited within the Ear, Nose, and Throat (ENT) service after a
baseline assessment. Simple randomization will be used in order to establish both therapeutic
groups with 45 patients in each group.
Group A: Patients taken care in consultation within the ENT service which provides
oro-myo-functional classical rehabilitation.
Group B: Patients taken care in external consultation who receive oro-myo-functional
rehabilitation through a virtual rehabilitation program targeted at the smile, in their place
of living in virtual conditions.
The patients must have been diagnosed with unilateral peripheral facial palsy, according to
House and Brackmann international classification.
Inclusion time : 18 months
Between-two-groups analysis will be conducted in order to compare a targeted and intensive
implementation-intention rehabilitation such as virtual rehabilitation program to standard
therapy. This virtual therapy will consist in repeating mentally movement desired, so that it
will be more spontaneously executed in the every-day-life situation.
Description:
Facial palsy can be divided into supranuclear lesion (central facial palsy) and infranuclear
lesion such as Bell's Palsy, an idiopathic disease. The peripheral facial paralysis (PFP) is
a frequent but little-known pathology (20 / 100 000 inhabitants in France a year). Oro-facial
functions and the ability to convey emotional facial information are seriously affected by
facial palsy, thereby reducing patient's quality of life. The PFP can have several
repercussions on the functional, aesthetic, social, occupational and psychological levels.
Evolution and prognosis depend not only on its etiology and gravity, but also on the
precocity and the quality of the medical and paramedical care. It is essential to assess
functional and psychological issues before beginning an adapted global therapeutic care.
Although these depressive symptoms can be explained by multiple factors, the inability to
smile would be one of the triggering factors of depression. The facial feedback hypothesis
could be one of many explications because smiling induces a positive emotional state and a
feeling of well-being. In PFP, patients must cope with their difficulties to smile. Their
facial behaviour affected their own emotional experiences.
Time required for improvement and risk of sequelae are proportional in the severity of the
paralysis (speed of installation and axonal loss). Do the patients benefiting from virtual
care have a deadline of recovery faster than control patients? Does a virtual rehabilitation
program, home delivered, which is targeted at the smile improve symmetric movements and
reduce psychological and functional issues?
The main purpose of the present study is to determine if virtual rehabilitation program is
relevant compared to standard therapy. The second aim is to characterize the efficiency by
analysing the time required to obtain a stable score of 4 in the Sunnybrook test.
A secondary objective will be to decrease the functional and social repercussions of the
facial paralysis with an intensive and targeted therapy of the smile. Furthermore, a virtual
rehabilitation program will be implemented in an interactive platform.
To this end, a parallel randomized controlled trial (RCT) of the two groups will be
conducted: standard therapy versus virtual rehabilitation program. RCT involves a treatment
in which active participation of the patient is necessary so only the assessment will be
blinded. Facial motor skills (tongue, mouth and face motricity) are measured using electronic
devices, objective and subjective evaluation with pragmatic fields such as communication,
emotion and quality of life. The severity of patient's facial paralysis is appraised by the
House and Brackmann scale. This global assessment will be conducted before the beginning of
the therapy and every 3 months during 18 months.
The patients will be recruited within the ENT service after a baseline assessment. Simple
randomization will be used in order to establish both therapeutic groups with 45 patients in
each group.
Group A: Patients taken care in consultation within the ENT service which provides
oro-myo-functional classical rehabilitation.
Group B: Patients taken care in external consultation who receive oro-myo-functional
rehabilitation through a virtual rehabilitation program targeted at the smile, in their place
of living in virtual conditions.
Oro-myo-functional classical rehabilitation (Diels et al.):
Neuromuscular retraining is a problem solving approach to treatment using selective motor
training to facilitate symmetrical movement and control undesired gross motor activity
(synkinesis). Treatment consists to accomplish daily massages and facial exercises (ten
minutes per day). Motivation on the part of the patient is a crucial element in the success
of treatment Tools such as feedback and specific mirror exercises provide augmented sensory
information to enhance neural adaptation and learning. Patient education is the most basic
aspect of the therapeutic process. The facial therapist provides training in basic facial
anatomy, physiology and kinesiology pertinent to each patient's specific situation.
Treatment is based on functional profile. Techniques will be used to facilitate movement and
inhibit abnormal patterns refine motor control, coordination and complexity of movement. The
specific objectives of the reeducation are to mobilize the paralyzed hemiface and to avoid
the over-investment of the healthy hemiface via the relaxation. Focus: to inhibit the
abnormal over-activity rather than to strengthen muscles. Although each patient's program
differs, there are common aspects in the treatment of all patients.
The technique is based on three fundamental principles:
- Slow execution to maintain inhibition as exercise increases - minimal, incremental
movements. Initiating movements slowly and gradually allows the patient to observe and
modify the angle, strength and speed of the excursion as it occurs. As a result, new
motor control strategies are systematically developed and learned.
- Small movements enough to mimic expressive movements and decrease overflow. Small
movements preserve isolated responses of the facial muscles by limiting motor unit
recruitment to those muscles targeted.
- Symmetry. Patients are instructed in symmetrical exercise of movements to reinforce the
normal physiological response.
Clinic treatment sessions are designed to identify, develop and refine the movement patterns
that will be of greatest benefit to each patient. Patients practice these movement patterns
repeated in the clinic to assure accuracy. Through the home program, patients consistently
practice the strategies learned in the clinic.
Virtual Rehabilitation program:
It's in the e-health context that virtual rehabilitation program should be considered.
E-health is a recent term for healthcare practice supported by electronic processes and
communication. E-health is becoming more and more as the solution for universal access to
high quality care.
The virtual rehabilitation program is a computerized rehabilitation, remotely managed by the
therapist. This rehabilitation would meet patients' and therapists' expectations with the aim
of dealing with the lack of therapists trained in the specific rehabilitation of the PFP. It
will avoid too frequent and binding travels of the patients. Indeed, kilometric average of
paralyzed patients taken care in the ENT service in Pitié-Salpêtrière is about 88 km. This
virtual rehabilitation program would then meet the requirements of the law '' Hospital,
Patient, Health and Territory '' of July 29th, 2009.
This virtual rehabilitation could also help patients to stay motivated by involving them
actively in the rehabilitation process. In fact, the patient is an autonomous actor of his
own rehabilitation. Furthermore, visual feedback provided by the avatar will help them to
execute movements in a proper way
Patient data is transferred to the therapists. At distance, the clinician is able to
straighten the exercises to execute and to update the method while waiting for the next
patient consultation.
The patient will be in front of his screen and the avatar will produce '' praxies'' according
to the evolution and the severity of the PFP (House and Brackmann scale). It is recommended
to observe the avatar repeatedly (three times a day for two weeks) so that, the patient will
learn the appropriate motor schemes. Then, the patient will apply the ''
implementation-intention '' technique in order to find the movement in any circumstances.
This technique consists in repeating mentally in advance the deliberate movement, so that it
will be executed more spontaneously in every-day-life situation.
Administration tool presents two sectors: it allows on one hand to consult the recorded
patients (addition, modifications, consultation of the exercises video, rehabilitation
management and updating, indication of the next recommended exercises, addition of a note for
the next session...). On the other hand, it allows to manage the exercises which include a
number of poses. For every pose, maintaining poses time and number of iterations of the pose
is indicated.
Digital, still sub-used technology, represents a real potential to improve professional
practices.
The patient training tool is a Windows run-time software which connects to the database and
downloads the exercises of the session. This connexion involves an automatic identification.
The software begins with a message posted by the therapist. Then, a simple interface,
including a half-screen posting what sees the webcam and another half-screen showing the
avatar which serves as a model for the training sessions. The patients are able to record
their own pose and to try again if they need to. In the end, a message indicates the end of
the current session.
Statistical Analysis:
Between-two-groups analysis will be conducted in order to compare a targeted and intensive
implementation-intention rehabilitation such as virtual rehabilitation program to standard
therapy. This virtual therapy will consist in repeating mentally movement desired, so that it
will be more spontaneously executed in the every-day-life situation.
All the quantitative variables, as the Sunnybrook score, the bilabial strength, the
House-Brackmann score, the MADRS score and the Quality of Life score will be described by
their average score, standard deviation, median score, minimum and maximum score.
Category-specific variables as Spielberg stress scale, Mouth-tongue-face motricity assessment
will be described by their frequencies and their percentages. Missing data will be taken into
account in these calculations Reliable intervals in 95% will be supplied when it will be
necessary.
Percentages in both groups will be compared by Pearson X2 tests or Fisher tests according to
the distribution. Continuous data will be compared by Student tests or Mann-Whitney tests,
according to their distribution. P-values must be lower than 0,05 in order to be considered
as statistically significant..
Analyses will be realized in intention to treat, under the responsibility of the
Biostatistics pole of Clinical Research Unit (URC) Pitié-Salpêtrière Charles Foix, with the
software SAS 9.2 (SAS(AIRLOCK,SIEVE,AIRLOCKS) INSTITUTE, CARY, NC).
