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IRCT20241013063348N1 IRCT 2024-12-04 Esfahan University of Medical Sciences Studying the effect of Kyphologic and Maria Adelaide Orthoses on the Sagittal Spinal Curves Studying the effect of Kyphologic and Maria Adelaide Orthoses on the Sagittal Spinal Curves in people with Scheuermann’s Kyphosis: a randomized clinical trial 2024-12-20 anticipated 10 Complete https://irct.ir/trial/79600 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to control the confounding variables, the samples are randomly divided into two equal groups using the kyphological orthosis and the Maria Adelaide orthosis users. In random allocation, the size of each block is considered to be four people. The test group includes the users of kyphological orthosis and is marked with the letter N. The control group includes users of the Maria Adelaide orthosis and is marked with the letter O. Considering the two test and control groups, the number of 6 blocks is obtained. The arrangement of the members of each block will be (NNOO), (NOON), (NONO), (OONN), (ONNO) and (ONON). Then these 6 modes are written separately on the paper and poured into a container. With two draws, the number of four sample people for each group and eight people in total are selected. To choose the other two, we continue the lottery until one of the blocks (NOON), (NONO), (ONNO) or (ONON) comes out of the lottery. N/A Scheuermann’s Kyphosis. Intervention 1: Test group: Kyphologic Orthosis، It is a thermoplastic TLSO orthosis that extends anteriorly from the cavity of the Coracoid appendage to the symphysis pubis and posteriorly from the apex of the thoracic arch to the sacrum bone. This belt opens from the front and does not cover the areas of the gluteal muscles. Intervention 2: Control group: Adelaide Orthosis، A thermoplastic TLSO orthosis that has a pelvic girdle. This pelvic girdle extends anteriorly from the xiphoid process to the pubic region, and posteriorly, the posterior longitudinal pads extend from the hip region to the thoracic kyphosis region. The pelvic belt opens from the back. In the anterior part of the brace, there is a sternal pad in the area below the supra sternal incision, and this pad is connected to the pelvic belt by two side metal bars. Yes - There is a plan to make this available What will be shared: Study information other than individual information is shared with other researchers. When: Information will be shared after results or data summaries are shared. To whom: Information is shared for academic purposes only. Conditions: Information is shared for the research and teaching of applicants. Where to obtain: People can get the information from the responsible person. How to obtain: Applications must be sent via email. (sadeghi@rehab.mui.ac.ir) Comments:
public Dr. Ebrahim Sadeghi
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5096 sadeghi@rehab.mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Ebrahim Sadeghi
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5096 sadeghi@rehab.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) The kyphosis angle of the thoracic or thoracolumbar region is more than 45 degrees Risser sign is between zero and two The apex of the arch is at T7 or lower There should be no prohibition to use an orthosis 8 years 16 years Both The kyphosis angle of the thoracic region should be more than 75 degrees In addition to kyphosis, have scoliosis have musculoskeletal, neurological or metabolic diseases at the same time BMI is more than 30 Deformity of the spine is congenital Have a history of spine surgery Treatment - Devices Treatment - Devices Test group: Kyphologic Orthosis، It is a thermoplastic TLSO orthosis that extends anteriorly from the cavity of the Coracoid appendage to the symphysis pubis and posteriorly from the apex of the thoracic arch to the sacrum bone. This belt opens from the front and does not cover the areas of the gluteal muscles Control group: Adelaide Orthosis، A thermoplastic TLSO orthosis that has a pelvic girdle. This pelvic girdle extends anteriorly from the xiphoid process to the pubic region, and posteriorly, the posterior longitudinal pads extend from the hip region to the thoracic kyphosis region. The pelvic belt opens from the back. In the anterior part of the brace, there is a sternal pad in the area below the supra sternal incision, and this pad is connected to the pelvic belt by two side metal bars. Cervical Lordosis Angle. Timepoint: Before, one month and six months after the intervention. Method of measurement: EOS radiography device operator software. Thoracic Kyphosis Angle. Timepoint: Before, one month and six months after the intervention. Method of measurement: EOS radiography device operator software. Lumbar Lordosis Angle. Timepoint: Before, one month and six months after the intervention. Method of measurement: EOS radiography device operator software. Sagittal Vertical Axis. Timepoint: Before, one month and six months after the intervention. Method of measurement: EOS radiography device operator software. Sacral Inclination Angle. Timepoint: Before, one month and six months after the intervention. Method of measurement: EOS radiography device operator software. Pelvic Tilt Angle. Timepoint: Before, one month and six months after the intervention. Method of measurement: EOS radiography device operator software. Satisfaction score. Timepoint: Six months after the intervention. Method of measurement: Questionnaire survey of orthosis and prosthesis users. Esfahan University of Medical Sciences Approved 2024-10-07 Ethics Committee of Faculty of Nursing, Management and Rehabilitation - Isfahan University of Medica Hezar jarib Ave Isfahan Isfehan Iran (Islamic Republic of)