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IRCT20200516047459N6 IRCT 2022-01-09 Esfahan University of Medical Sciences The effect of spinal orthosis on spinal deviation Evaluation of immediate effect of designed brace on curve correction of adolescent idiopathic scoliosis 2021-12-16 anticipated 5 Complete https://irct.ir/trial/60789 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A scoliosis. Intervention group (spine brace): In the first stage, the CT scan data of 5 people with scoliosis who have already had a CT scan at the request of a doctor and whose information is available in radiology centers, will be used for 3D modeling of the finite element, then design The optimal brace will be based on the 3D model made. After determining the optimal model of load application, this optimal model will be used in the second phase of the study in the treatment of braces of 5 people with juvenile idiopathic scoliosis. Then the patient wears the braces full time (23 hours a day) for one month and The amount of recurrence curve is calculated after one month of standing on the frontal plate while the patient is wearing a brace.. No - There is not a plan to make this available Justification or reason for not sharing IPD is Documents and information about the participants are confidential.
public Masoud Rafiaei
No.318 ,Rehabilitation college, Isfahan University and medical sciences, Hezar Jerib Street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5043 ma.rafiaei@gmail.com Esfahan University of Medical Sciences scientific Masoud Rafiaei
No.318 ,Rehabilitation college, Isfahan University and medical sciences, Hezar Jerib Street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5043 ma.rafiaei@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) The age range of participants is between 10 and 14 years. Racer mark of participants should be between 0 and 2, The initial curvature of the participants should be between 25 and 45 degrees, The apex of the scoliosis curve is below the fifth thoracic vertebra; 10 years 14 years Both Participants have reached skeletal maturity or more than one year has passed since their maturity. M41.115 Juvenile idiopathic scoliosis, thoracolumbar region Rehabilitation Intervention group (spine brace): In the first stage, the CT scan data of 5 people with scoliosis who have already had a CT scan at the request of a doctor and whose information is available in radiology centers, will be used for 3D modeling of the finite element, then design The optimal brace will be based on the 3D model made. After determining the optimal model of load application, this optimal model will be used in the second phase of the study in the treatment of braces of 5 people with juvenile idiopathic scoliosis. Then the patient wears the braces full time (23 hours a day) for one month and The amount of recurrence curve is calculated after one month of standing on the frontal plate while the patient is wearing a brace. The size of the spine curvature that will be taken through the photograph by estimating the cobb angle. Timepoint: Before, Immediately after and one month after wearing the brace. Method of measurement: In order to evaluate the immediate effect of orthosis, a radiograph of the patient's spine is first taken standing and the angle of curvature of the spine is determined by a percussion method. Angle of curvature of the spine. Timepoint: Before, immediately after and a month later. Method of measurement: Evaluate the angle of curvature using graphic photography. Esfahan University of Medical Sciences Approved 2021-11-13 Ethics committee of Isfahan University of Medical Sciences No.318 ,Rehabilitation college, Isfahan University and medical sciences, Hezar Jerib Street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)