Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532903
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-24
Brief Title:
Functional Recovery From Facial Paralysis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Functional Recovery of Facial Paralysis in People With Different Kinesic Treatment Options
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 0423 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 Bells 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
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 0423 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 Bells 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 Bells palsy in the City of Corrientes
Units of analysis each person with peripheral facial paralysis or Bells 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 Bells 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 andor 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 persons 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 Left2
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 andor 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 patients 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 type experimental Design Controlled clinical research single blind hybrid Universe all people with peripheral facial paralysis or Bells palsy in the City of Corrientes
Units of analysis each person with peripheral facial paralysis or Bells 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 Bells 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 andor 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 persons 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 Left2
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 andor 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None