Functional Recovery From Facial Paralysis

NCT06532903 | Recruiting DMC

• 2 other identifiers: Resol N° 04/23 Comité BioéticaProyecto 21I001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Facial Paralysis; Facial Palsy; Synkineses

Keywords

electrostimulation; peripheral facial paralysis; facial muscles; mime; selective muscle electrostimulation

Outcome Measures

Primary Outcomes (2)

• FUNCTIONAL RECOVERY

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

  24 months

• Functional recovery time

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

  24 months

Study Arms (2)

Study group

EXPERIMENTAL

Patients with peripheral facial paralysis who will receive muscle reeducation in front of the mirror and selective muscle electrostimulation with exponential currents

Other: Selective muscle electrostimulation with exponential current

control group

ACTIVE COMPARATOR

Patients with peripheral facial paralysis who will receive facial muscle reeducation in front of the mirror without selective muscle electrostimulation with exponential current

Other: Facial muscle reeducation in front of the mirror

Interventions

Selective muscle electrostimulation with exponential current OTHER

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.

Study group

Facial muscle reeducation in front of the mirror OTHER

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.

control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a medical referral that indicates as a diagnosis:
• Peripheral facial paralysis
• Bell's palsy
• Frigori facial paralysis
• Idiopathic facial paralysis, who have NOT received prior kinesic treatment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional del Nordeste, Argentina: lead
• National Council of Scientific and Technical Research, Argentina: collaborator

Study Sites (1)

Servicio Universitario de Kinesiologia

Corrientes, 3400, Argentina

RECRUITING

Related Publications (1)

• Di Pietro A, Cameron M, Campana V, Leyes L, Zalazar Cinat JAI, Lochala C, Johnson CZ, Hilldebrand A, Loyo M. Efficacy of adding selective electrical muscle stimulation to usual physical therapy for Bell's palsy: immediate and six-month outcomes. Eur J Transl Myol. 2023 Oct 24;33(4):11630. doi: 10.4081/ejtm.2023.11630.

  PMID: 37877154 BACKGROUND

MeSH Terms

Conditions

Facial Paralysis; Synkinesis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias

Study Officials

• JESSICA A ZALAZAR, INVESTIGADOR

  Universidad Nacional del Nordeste, Argentina

  STUDY DIRECTOR

Central Study Contacts

JESSICA A ZALAZAR, INVESTIGADOR

CONTACT

+5493624791093; jessicazalazarcinat@med.unne.edu.ar

LAURA E LEYES, INVESTIGADOR

CONTACT

+5493794759014; lauraleyes@med.unne.edu.ar

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The external evaluators will determine the degree of facial dysfunction according to House Brackman and the score found in the Sunnybrook system, values that will be recorded on a blind evaluation sheet. The procedure will be carried out after the first session and upon discharge of the patients. That is, they will carry out an initial and final evaluation of the patients, without knowing the physical treatment they received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master in Research in Health Sciences - Graduate in Kinesiology and Physiatry

Model Details: Two groups will be defined: * Control: Patients with peripheral facial paralysis who will receive standard kinesic treatment (facial muscle reeducation without selective muscle electrostimulation) * Study: Patients with peripheral facial paralysis who will receive standard kinesic treatment (with muscle reeducation) and selective muscle electrostimulation. People who voluntarily attend the University Kinesiology Service in the indicated period will be selected based on the aforementioned inclusion and exclusion criteria, thus constituting an intentional sample. Patients will be assigned to each group in a systematic random manner.

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: August 1, 2024
• Study Start: June 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

AR (1)