Peripheral Facial ParalysisNCT06532903
Functional Recovery From Facial Paralysis
A study testing Selective muscle electrostimulation with exponential current and Facial muscle reeducation in front of the mirror in people with Peripheral Facial Paralysis and Facial Palsy, run by Universidad Nacional del Nordeste, Argentina at 1 site in Argentina.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Facial Paralysis, Facial Palsy, Synkineses
- What is being tested?
- Selective muscle electrostimulation with exponential current and Facial muscle reeducation in front of the mirror
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jun 2023to 31 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Servicio Universitario de Kinesiologia
Corrientes, 3400
ELIZABETH RUTH LORENA ACOSTA, INVESTIGADOR, +5493794710307, loresukunne@gmail.com
MARIA MARCELA BARRIOS, INVESTIGADOR, +54 9 3794 57-5048, marcebarrios13@med.unne.edu.ar
About this study
Official title: Evaluation of Functional Recovery of Facial Paralysis in People With Different Kinesic Treatment Options.
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.
Read the detailed description
Methodology:
Study type: experimental Design: Controlled clinical research, single blind (hybrid). Universe: all people with peripheral facial paralysis or Bell's palsy in the City of Corrientes.
Units of analysis: each person with peripheral facial paralysis or Bell's palsy who attends the UNNE University Kinesiology Service. This center is taken as a reference, since it is a reference place for the referral of patients with this diagnosis, it is open to the general public and free of charge.
Sampling: a probabilistic sampling will be carried out. Sample size (n): 152 patients Expected loss ratio (R): 15% Loss-adjusted sample: 179 patients
The following inclusion criteria will be taken into account:
-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.
Patients with central facial paralysis (facial paralysis associated with stroke), with peripheral facial paralysis of more than 6 months' duration, will be excluded from the study. Patients who present dermal lesions that interfere with the application of electrical currents (open wounds, lacerations or burns) and/or who attend with a medical prescription that advises against the use of electrostimulation in writing.
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.
The assignment of patients to each group will be carried out in a systematic random manner.
People who voluntarily attend the University Kinesiology Service in the indicated period will be selected based on the aforementioned inclusion and exclusion criteria. Patients will be assigned to each group in a systematic random manner. A characteristic of controlled clinical trials is double blinding, a condition that will be resigned since it is impossible for the kinesiologist to ignore what treatment is assigned to the patient, since he himself is the one who applies it. On the other hand, it is worth mentioning that the blinding that will be included will be the initial and final evaluation of the people included in the study, that is; A group of professionals trained in facial evaluation scales will receive the initial and final videos of the patients without knowing the treatment they received.
study variables:
Functional recovery from facial paralysis dimension:
-Specific muscle function: - Ability to close eyes completely and symmetrically.
Mouth occlusion at the beginning and end of treatment -Value: Does not occlude: 0 - Occludes: 1 Capacity to contain liquids and air. VALUE: Does not contain: 0 Contains: 1
-Functional recovery time. Number of treatment sessions carried out until the person's kinesic discharge.
VALUE: Short term: up to 7 sessions -Medium term: up to 15 sessions -Long term:
greater than 15 sessions
- Facial symmetry: The correspondence between the size, shape and location of facial features on one side with respect to the opposite side. Present: 1 Absent: 0
- Laterality of paralysis Side of peripheral facial paralysis Right: 1 Left:2
Individual characteristics of people with peripheral facial paralysis
- Age
- sexual identity
Days of evolution of the PFP: Number of days of evolution of the paralysis before starting treatment -Short term: less than 7 days -Medium term: up to 15 days -Long term: greater than 15 days
previous pathological history
presence of synkinesis
Facial function assessment scales: House Brackman and Sunnybrook
Registration method
To record the data obtained, the following is done: filming, photographic recording of facial muscle functions with a NIKON DSC COOLPIX B500® camera; For the written record, a daily monitoring sheet is used that includes: anamnesis, clinical evaluation, functional evaluation, electrostimulation parameters and re-education.
Position of the patient for taking photographic and videographic records: the patients are seated in front of the camera, placed on a tripod, focusing on the face in the foreground, taking an imaginary biclavicular lower line as the frame limit, with a clear background. . In this way, the initial evaluation, evolution and final assessment of each patient was documented.
Filming and photographic records were carried out without zoom to avoid distortions in the image or defects in its resolution.
DESCRIPTION OF THE TREATMENT APPLIED TO EACH GROUP FACIAL REEDUCATION Protocol Muscle re-education: Symmetrical facial movements are requested, activating the muscles of the affected side, avoiding the participation of the unaffected side. We 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 was trained, inflating the cheekbones and moving air from one side to the other, avoiding compensations.
Depending on the degree of facial dysfunction and its condition, the kinesiologist performs irradiation, stretch reflex, movement facilitation and/or its inhibition. Three series of five repetitions of each gesture described were done.
Selective muscle electrostimulation protocol for the study group:
Each patient underwent an "electroevaluation" with an exponential current generating device (NEUROMATIC 700 brand Meditea®) which consisted of a test using facial stimulation with different pulse widths (in milliseconds) and intensities (in milliamps) with current. exponential. It was observed in which parameters a frank, visible and selective contraction was achieved, avoiding muscle fatigue. This procedure was performed daily, allowing selective muscle stimulation and a dosed application of the physical agent used.
Technique for applying selective muscle electrostimulation: a direct technique was used with a dispersive electrode in the patient's cervical spine and an active punctal electrode in the facial muscles.
Ethical considerations:
The process of reading, understanding, accepting and signing the informed consent was carried out in a prior interview, before starting the treatment. This document included the treatment methods used, the objectives of the study, the free follow-up, the commitment of both parties, as well as the formal dissemination mechanisms used regarding the results of the work to each participating patient. The risks inherent to kinesic practice were detailed and the patient was informed of the mechanisms used to ensure the quality of care provided.
- Conditions
- Peripheral Facial Paralysis, Facial Palsy, Synkineses
- Being tested
- Selective muscle electrostimulation with exponential current, Facial muscle reeducation in front of the mirror
- Keywords
- electrostimulation, peripheral facial paralysis, facial muscles, mime, selective muscle electrostimulation
- Medical subject headings
- Facial Paralysis, Synkinesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective muscle electrostimulation with exponential currentOther
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 mirrorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Facial muscle reeducation in front of the mirror |
What is being measured
The primary outcome is the main question the study is designed to answer.
FUNCTIONAL RECOVERY
ability to make facial gestures evaluated using the House Brackman scale and the Sunnybroock system
Measured: 24 months
Functional recovery time
number of sessions necessary to achieve recovery of facial muscle function and ability to make facial gestures.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Jun 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (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 Peripheral Facial ParalysisStudies of the same condition, open and under way.
- 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
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional del Nordeste, Argentina
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Scientific and Technical Research, Argentina
- Responsible party
- Principal investigator, Jessica Andrea Isabel Zalazar Cinat, Universidad Nacional del Nordeste, Argentina
- Investigators
- JESSICA A ZALAZAR, INVESTIGADOR, Study director, Universidad Nacional del Nordeste, Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532903
- Sponsor's protocol ID
- Resol N° 04/23 Comité Bioética
- Other IDs
- Proyecto 21I001
- Status last verified
- Jul 2024
- First submitted
- 24 Jun 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37877154
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functional Recovery of Facial Paralysis in People With Different Kinesic Treatment Options.
- ClinicalTrials.gov ID
- NCT06532903
- Acronym / sponsor ID
- Resol N° 04/23 Comité Bioética
- Conditions
- Peripheral Facial Paralysis, Facial Palsy, Synkineses
- Keywords
- electrostimulation, peripheral facial paralysis, facial muscles, mime, selective muscle electrostimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidad Nacional del Nordeste, ArgentinaUniversity, hospital or other
- Collaborators
- National Council of Scientific and Technical Research, Argentina
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Aug 2024 (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.
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.
Detailed description
Methodology:
Study type: experimental Design: Controlled clinical research, single blind (hybrid). Universe: all people with peripheral facial paralysis or Bell's palsy in the City of Corrientes.
Units of analysis: each person with peripheral facial paralysis or Bell's palsy who attends the UNNE University Kinesiology Service. This center is taken as a reference, since it is a reference place for the referral of patients with this diagnosis, it is open to the general public and free of charge.
Sampling: a probabilistic sampling will be carried out. Sample size (n): 152 patients Expected loss ratio (R): 15% Loss-adjusted sample: 179 patients
The following inclusion criteria will be taken into account:
-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.
Patients with central facial paralysis (facial paralysis associated with stroke), with peripheral facial paralysis of more than 6 months' duration, will be excluded from the study. Patients who present dermal lesions that interfere with the application of electrical currents (open wounds, lacerations or burns) and/or who attend with a medical prescription that advises against the use of electrostimulation in writing.
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.
The assignment of patients to each group will be carried out in a systematic random manner.
People who voluntarily attend the University Kinesiology Service in the indicated period will be selected based on the aforementioned inclusion and exclusion criteria. Patients will be assigned to each group in a systematic random manner. A characteristic of controlled clinical trials is double blinding, a condition that will be resigned since it is impossible for the kinesiologist to ignore what treatment is assigned to the patient, since he himself is the one who applies it. On the other hand, it is worth mentioning that the blinding that will be included will be the initial and final evaluation of the people included in the study, that is; A group of professionals trained in facial evaluation scales will receive the initial and final videos of the patients without knowing the treatment they received.
study variables:
Functional recovery from facial paralysis dimension:
-Specific muscle function: - Ability to close eyes completely and symmetrically.
Mouth occlusion at the beginning and end of treatment -Value: Does not occlude: 0 - Occludes: 1 Capacity to contain liquids and air. VALUE: Does not contain: 0 Contains: 1
-Functional recovery time. Number of treatment sessions carried out until the person's kinesic discharge.
VALUE: Short term: up to 7 sessions -Medium term: up to 15 sessions -Long term:
greater than 15 sessions
- Facial symmetry: The correspondence between the size, shape and location of facial features on one side with respect to the opposite side. Present: 1 Absent: 0
- Laterality of paralysis Side of peripheral facial paralysis Right: 1 Left:2
Individual characteristics of people with peripheral facial paralysis
- Age
- sexual identity
Days of evolution of the PFP: Number of days of evolution of the paralysis before starting treatment -Short term: less than 7 days -Medium term: up to 15 days -Long term: greater than 15 days
previous pathological history
presence of synkinesis
Facial function assessment scales: House Brackman and Sunnybrook
Registration method
To record the data obtained, the following is done: filming, photographic recording of facial muscle functions with a NIKON DSC COOLPIX B500® camera; For the written record, a daily monitoring sheet is used that includes: anamnesis, clinical evaluation, functional evaluation, electrostimulation parameters and re-education.
Position of the patient for taking photographic and videographic records: the patients are seated in front of the camera, placed on a tripod, focusing on the face in the foreground, taking an imaginary biclavicular lower line as the frame limit, with a clear background. . In this way, the initial evaluation, evolution and final assessment of each patient was documented.
Filming and photographic records were carried out without zoom to avoid distortions in the image or defects in its resolution.
DESCRIPTION OF THE TREATMENT APPLIED TO EACH GROUP FACIAL REEDUCATION Protocol Muscle re-education: Symmetrical facial movements are requested, activating the muscles of the affected side, avoiding the participation of the unaffected side. We 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 was trained, inflating the cheekbones and moving air from one side to the other, avoiding compensations.
Depending on the degree of facial dysfunction and its condition, the kinesiologist performs irradiation, stretch reflex, movement facilitation and/or its inhibition. Three series of five repetitions of each gesture described were done.
Selective muscle electrostimulation protocol for the study group:
Each patient underwent an "electroevaluation" with an exponential current generating device (NEUROMATIC 700 brand Meditea®) which consisted of a test using facial stimulation with different pulse widths (in milliseconds) and intensities (in milliamps) with current. exponential. It was observed in which parameters a frank, visible and selective contraction was achieved, avoiding muscle fatigue. This procedure was performed daily, allowing selective muscle stimulation and a dosed application of the physical agent used.
Technique for applying selective muscle electrostimulation: a direct technique was used with a dispersive electrode in the patient's cervical spine and an active punctal electrode in the facial muscles.
Ethical considerations:
The process of reading, understanding, accepting and signing the informed consent was carried out in a prior interview, before starting the treatment. This document included the treatment methods used, the objectives of the study, the free follow-up, the commitment of both parties, as well as the formal dissemination mechanisms used regarding the results of the work to each participating patient. The risks inherent to kinesic practice were detailed and the patient was informed of the mechanisms used to ensure the quality of care provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Selective muscle electrostimulation with exponential currentPatients with peripheral facial paralysis who will receive muscle reeducation in front of the mirror and selective muscle electrostimulation with exponential currents |
| control group | Active comparator | Other: Facial muscle reeducation in front of the mirrorPatients with peripheral facial paralysis who will receive facial muscle reeducation in front of the mirror without selective muscle electrostimulation with exponential current |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Selective muscle electrostimulation with exponential currentAn 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. | Other | Study group |
| Facial muscle reeducation in front of the mirrorMuscle 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. | Other | control group |
Primary outcome
FUNCTIONAL RECOVERY
Time frame: 24 months
ability to make facial gestures evaluated using the House Brackman scale and the Sunnybroock system
Functional recovery time
Time frame: 24 months
number of sessions necessary to achieve recovery of facial muscle function and ability to make facial gestures.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Background: PubMed 37877154Di 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.
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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.
JESSICA A ZALAZAR, INVESTIGADOR study director
Universidad Nacional del Nordeste, Argentina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective muscle electrostimulation with exponential current and Facial muscle reeducation in front of the mirror in people with Peripheral Facial Paralysis and Facial Palsy, run by Universidad Nacional del Nordeste, Argentina at 1 site in Argentina.
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 5 inclusion and 4 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 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. 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 JESSICA A ZALAZAR, INVESTIGADOR (+5493624791093, jessicazalazarcinat@med.unne.edu.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FUNCTIONAL RECOVERY (time frame: 24 months). The study lists 2 primary outcomes in all. 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 NCT06532903, 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 1 Aug 2024.