Functional Recovery From Facial Paralysis

ConditionsPeripheral Facial Paralysis Facial Palsy Synkineses

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorUniversidad Nacional del Nordeste, Argentina

About this trial

This is a controlled, single-blind (hybrid) clinical investigation that aims to analyze the process of recovery of muscle function in people with peripheral facial paralysis who receive kinesthetic treatment with electrostimulation compared to those who receive treatment without electrostimulation, in the UNNE University Kinesiology Service, during the period 2023-2025, to promote early reintegration into their social activities of daily life.

An initial evaluation will be carried out, the movements that cause the requested gestures will be observed and recorded and recorded on a monitoring sheet and on video. The House Brackman and Sunnybrook scale will be used to measure functional outcomes. The initial and final evaluations will be external and blind. Patients will sign informed consent approved by Resolution No 04/23 of the Health Sciences Research Bioethics Committee.

The following inclusion criteria will be taken into account: patients with a medical referral that indicates a diagnosis of peripheral facial paralysis, Bell's palsy, frigori facial paralysis, idiopathic facial paralysis, who have not received previous kinesic treatment. Patients with central facial paralysis (associated with stroke), with peripheral facial paralysis of more than 6 months of evolution, who present dermal lesions that interfere with the application of electrical currents (open wounds, lacerations or burns) will be excluded from the study. ) In addition, those patients who attend with a medical prescription that advises in writing against the use of electrostimulation will be excluded.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Peripheral facial paralysis

Bell's palsy

Frigori facial paralysis

Idiopathic facial paralysis, who have NOT received prior kinesic treatment.

Disqualifiers

Patients with central facial paralysis (facial paralysis associated with stroke)

Patients with peripheral facial paralysis of more than 6 months' duration, will be excluded from the study.

Patients who present skin lesions that interfere with the application of electrical currents (open wounds, lacerations or burns)

Patients who attend with a medical prescription that advises against the use of electrostimulation in writing.

Trial design

Design model

Parallel

Treatments tested in this trial

Selective muscle electrostimulation with exponential current
Other intervention
An electroevaluation will be performed, with an exponential current generator equipment, using Meditea® brand Neuromatic 700 equipment, which consists of a first application of the current, the pulse width (in milliseconds) in which a contraction is achieved will be sought. frank, visible and selective of the facial muscle that is being stimulated. The purpose is to identify the pulse width and the lowest intensity to obtain a frank, visible and selective contraction, understood as the best quality.
Facial muscle reeducation in front of the mirror
Other intervention
Muscle re-education: Symmetrical facial movements will be requested, activating the muscles of the affected side, avoiding the participation of the unaffected side. We will work with the patient sitting in front of a mirror, asking him to perform the following actions or gestures: raise his eyebrows, frown, close his eyes (tightly and blink), smell an unpleasant odor, show his fangs, blow a kiss, blow , fake smile (lip corner pulled back horizontally), frank smile (lip corner pulled back and up, showing teeth), kiss and "pout". The functional capacity of the mouth will be trained, inflating the cheekbones and moving the air from one side to the other, avoiding compensations. Depending on the degree of facial dysfunction and its condition, the kinesiologist will perform a stretch reflex, facilitation of movement and/or inhibition of it. Three series of five repetitions of each gesture described will be done.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Study groupExperimental treatment 1 intervention

Group B: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

FUNCTIONAL RECOVERY

ability to make facial gestures evaluated using the House Brackman scale and the Sunnybroock system

Time frame

24 months

Functional recovery time

number of sessions necessary to achieve recovery of facial muscle function and ability to make facial gestures.

Time frame

24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Nacional del Nordeste, Argentina

Lead sponsor

National Council of Scientific and Technical Research, Argentina

Collaborator

Source ClinicalTrials.gov

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