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IRCT20171215037872N1 IRCT 2019-07-13 Shiraz University of Medical Sciences Efficacy of Repetitive Transcranial Magnetic Stimulation to Reduce Muscle Spasticity Efficacy of Repetitive Transcranial Magnetic Stimulation to Reduce Muscle Spasticity in Patients with Traumatic Brain Injury 2018-12-22 anticipated 40 Complete https://irct.ir/trial/28480 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random assignment method In this study, the method of the permutation block will be such that A represents the person receiving the intervention and B represents the person who does not receive the intervention. This method, taking into account the six-membered blocks so that the total number of possible quadrupole permutations is equal to 4, includes: AABB, ABAB, BABA, BBAA. Then, with Using the random numbers table and assigning the code from 0 to 9 to each permutation, (randomized list of 60) (considering the drop in patients from the study), which includes 15 blocks of 4 (60 * 4 * 60 total number of samples ) And the order of assignment of each method to each of the participating samples is determined. For example: (ABAB Code 0, AABB Code 1, BABA Code 2, BBAA Code 3 to 9) Then, using the random numbers table, the starting point is selected randomly and 15 randomly selected (row or column) is selected and the assigned permutation is written to each number. (The order of placing permutations next to each other is left to right respectively) and how all 60 people will be assigned to the two groups A and B, Blinding description: The control group was studied by the coil off of the sham stimulation device. The patient's examiner who evaluates spasticity is not aware of the lack or existence of the device . N/A Spasticity in traumatic brain injury. Intervention 1: Intervention group: Includes 20 traumatic brain injury patients who are eligible for the study and randomly selected. The motor cortex is determined by a coil of the 8th form of magnetic stimulation. Prior to that, the threshold of motion of the intervertebral muscles of the back of the other side is determined. The lowest single pulse intensity is tms with a stimulated motor potential of 50 millivolts, determined by EMG. The following magnetic stimulation is applied as follows: Frequency: 1 Hz / pulse number: 1500 / intensity: 90% of the motor threshold Each person receives a TMS meeting for 10 days a day. Intervention 2: Control group: Twenty traumatic traumatic brain injury patients who were eligible for the study were randomly selected. The control group was studied by the coil off of the sham stimulation study. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After the data is collected and interventions are conducted on how to publish the decision. In case of publication in a newspaper article, the publisher decides on how to publish
public Sharareh Roshanzamir
16th floor,Gole narges building, Shahid Goodarzi street,Shahid Rajaee Blvd.
Shiraz Iran (Islamic Republic of) 7184839113 +98 71 3230 5410 sharareh.roshanzamir@gmail.com Shiraz University of Medical Sciences scientific Sharareh Roshanzamir
16th floor,Gole narges building, Shahid Goodarzi street,Shahid Rajaee Blvd.
Shiraz Iran (Islamic Republic of) 7184839113 +98 71 3230 5410 sharareh.roshanzamir@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age over 18 and under 75 years presence of muscle spasticity at grades 3 and 4 in at least one of the muscle compartments With muscle_ power grading over 3 18 years 75 years Both History of ischemic or hemorrhage stroke and multiple sclerosis Existence of joint dryness and adhesion Major fractures and history of cerebral cranial surgeries in the past positive history of cardiac arrhythmias positive history of brain aneurysm or seizure (focal or generalized) history of surgery involving metal or clips implants unstable Vital signs Chronic Pain S06.2 Diffuse traumatic brain injury Rehabilitation Rehabilitation Intervention group: Includes 20 traumatic brain injury patients who are eligible for the study and randomly selected. The motor cortex is determined by a coil of the 8th form of magnetic stimulation. Prior to that, the threshold of motion of the intervertebral muscles of the back of the other side is determined. The lowest single pulse intensity is tms with a stimulated motor potential of 50 millivolts, determined by EMG. The following magnetic stimulation is applied as follows: Frequency: 1 Hz / pulse number: 1500 / intensity: 90% of the motor threshold Each person receives a TMS meeting for 10 days a day. Control group: Twenty traumatic traumatic brain injury patients who were eligible for the study were randomly selected. The control group was studied by the coil off of the sham stimulation study. Muscle tone. Timepoint: The beginning of the study, before and after each intervention, one month after the end of the interventions. Method of measurement: Data collection is done through the Modified Ashworths Scale to evaluate the muscle tone that points to 0 to 4 for the patient's examination. Power of muscle. Timepoint: The beginning of the study, before and after each intervention, one month after the end of the interventions. Method of measurement: Using the MRC Score based on the range of patient's movement, the score is 0-5. Activity of daily living. Timepoint: The beginning of the study, before and after each intervention, one month after the end of the interventions. Method of measurement: The score for Barthel's score is 0-100 based on the patient's daily activity. Shiraz University of Medical Sciences Approved 2018-11-14 Ethics committee of Shiraz University of Medical Sciences Fifth Floor, Central Building of Shiraz University, Jomhuory Boulevard Shiraz Fars Iran (Islamic Republic of)