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IRCT20190618043931N3 IRCT 2023-10-02 Esfahan University of Medical Sciences High level laser in Bell's palsy Evaluation of the effect of high level laser in improving facial nerve function in patients with Bell's palsy 2023-10-12 anticipated 30 Complete https://irct.ir/trial/68533 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Referred patients are randomly divided into two intervention and control groups. In this way, each person is assigned a number and then they are entered into the study groups with the number randomization table. This randomization is without placement, Blinding description: The data analyst is unaware of which group each patient was placed in. N/A Bell's palsy. Intervention 1: Intervention group: high-power laser with Fisioline device in 12 sessions with a wavelength of 1064 and a frequency of 500 Hz is performed in the path of the facial nerve and exercises related to the facial nerve are taught. Regarding eye exercises, the patient is told to look down. Then gently place the index finger behind the upper eyelid and keep the eye closed. And with the fingers of the other hand, pull the eyebrow up. This exercise prevents the eyelids from tightening. After that, the patient tries to close the eyelids. press each other. Also, after this movement, the patient closes his eyes as if he were looking at the sunlight, in other words, he brings both eyelids closer to each other. To exercise in the mouth area, the patient should smile in such a way that the lips are closed and he can use his fingers to equalize the location of the corners of the mouth on both sides. After some time, the patient should perform this movement without the help of fingers and for a longer time. Gradually, the patient should raise only one side of the mouth and then repeat this movement for the other side. For the movements of the mouth and cheek area, the patient should also perform movements such as whistling and blowing. To exercise in the nasal area, the patient should try to take a deep breath by opening the nostrils and keep the mouth closed during this movement. It is recommended to do the exercises three times a day and each movement 5 times in Every turn should be done and exercises should be continued for 4 weeks. Intervention 2: Control group: exercises related to the facial nerve are taught. Regarding eye exercises, the patient is told to look down. Then gently place the index finger behind the upper eyelid and keep the eye closed. And with the fingers of the other hand, pull the eyebrow up. This exercise prevents the eyelids from tightening. After that, the patient tries to close the eyelids. press each other. Also, after this movement, the patient closes his eyes as if he were looking at the sunlight, in other words, he brings both eyelids closer to each other. To exercise in the mouth area, the patient should smile in such a way that the lips are closed and he can use his fingers to equalize the location of the corners of the mouth on both sides. After some time, the patient should perform this movement without the help of fingers and for a longer time. Gradually, the patient should raise only one side of the mouth and then repeat this movement for the other side. For the movements of the mouth and cheek area, the patient should also perform movements such as whistling and blowing. To exercise in the nasal area, the patient should try to take a deep breath by opening the nostrils and keep the mouth closed during this movement. It is recommended to do the exercises three times a day and each movement 5 times in Every turn should be done and exercises should be continued for 4 weeks. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentifiable individuals When: 2025 To whom: Researchers working in universities and scientific centers Conditions: no condition Where to obtain: Shila_haghighat @mui.ac.ir How to obtain: Send a request email and explain the purpose of using the data. Comments:
public Shila Haghighat
Alzahra hospital,Sofe Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3627 5139 shila_haghighat@med.mui.ac.ir Esfahan University of Medical Sciences scientific Shila Haghighat
Alzahra hospital,Sofe Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3627 5139 shila_haghighat@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with symptoms of Bell's palsy At least one month has passed since receiving initial treatment interventions no limit no limit Both Patients with malignancy, high blood pressure, uncontrolled diabetes mellitus, brain and nerve diseases, simultaneous multiple cranial nerve palsy, pregnancy and breastfeeding Patients with a history of recurrent facial paralysis or facial deformity G51.0 Bell's palsy Rehabilitation Rehabilitation Intervention group: high-power laser with Fisioline device in 12 sessions with a wavelength of 1064 and a frequency of 500 Hz is performed in the path of the facial nerve and exercises related to the facial nerve are taught. Regarding eye exercises, the patient is told to look down. Then gently place the index finger behind the upper eyelid and keep the eye closed. And with the fingers of the other hand, pull the eyebrow up. This exercise prevents the eyelids from tightening. After that, the patient tries to close the eyelids. press each other. Also, after this movement, the patient closes his eyes as if he were looking at the sunlight, in other words, he brings both eyelids closer to each other. To exercise in the mouth area, the patient should smile in such a way that the lips are closed and he can use his fingers to equalize the location of the corners of the mouth on both sides. After some time, the patient should perform this movement without the help of fingers and for a longer time. Gradually, the patient should raise only one side of the mouth and then repeat this movement for the other side. For the movements of the mouth and cheek area, the patient should also perform movements such as whistling and blowing. To exercise in the nasal area, the patient should try to take a deep breath by opening the nostrils and keep the mouth closed during this movement. It is recommended to do the exercises three times a day and each movement 5 times in Every turn should be done and exercises should be continued for 4 weeks. Control group: exercises related to the facial nerve are taught. Regarding eye exercises, the patient is told to look down. Then gently place the index finger behind the upper eyelid and keep the eye closed. And with the fingers of the other hand, pull the eyebrow up. This exercise prevents the eyelids from tightening. After that, the patient tries to close the eyelids. press each other. Also, after this movement, the patient closes his eyes as if he were looking at the sunlight, in other words, he brings both eyelids closer to each other. To exercise in the mouth area, the patient should smile in such a way that the lips are closed and he can use his fingers to equalize the location of the corners of the mouth on both sides. After some time, the patient should perform this movement without the help of fingers and for a longer time. Gradually, the patient should raise only one side of the mouth and then repeat this movement for the other side. For the movements of the mouth and cheek area, the patient should also perform movements such as whistling and blowing. To exercise in the nasal area, the patient should try to take a deep breath by opening the nostrils and keep the mouth closed during this movement. It is recommended to do the exercises three times a day and each movement 5 times in Every turn should be done and exercises should be continued for 4 weeks. Severity of facial nerve palsy in HBS system and electrodiagnostic study. Timepoint: At the beginning of treatment, 3 and 6 weeks after treatment. Method of measurement: HBS system and electrodiagnostic study. Esfahan University of Medical Sciences Approved 2022-01-19 Ethics committee of Esfahan University of Medical Sciences No.30,Taleghani Alley, East Hasht behesht Ave , Esfahan Esfahan Isfehan Iran (Islamic Republic of)