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IRCT20231110060014N1 IRCT 2024-01-06 Esfahan University of Medical Sciences Effectiveness of two cheneaue orthoses made by the CADCAM method and the conventional method in correcting idiopathic scoliosis in adolescent girls Comparison of two Cheneanu brace made by two methods: "using a frame and 3D scanning" and "conventional" method on cobb angle correction, apical vertebral rotation, kyphosis and lordosis in adolescent girls with idiopathic scoliosis: a randomized clinical trial 2024-01-21 anticipated 30 Complete https://irct.ir/trial/74687 interventional Randomization: Randomized, Blinding: Single 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 block method, including the test (users of the new Cheneau brace) and the control (users of the usual Cheneau brace). The way of random assignment in both groups is that the size of each block is considered to be 4 people, and based on this and considering the two experimental groups that have new braces (N) and the control group that have regular braces (O). , 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 states are written separately on paper and poured into a container, and with 8 rounds of lottery, the number of 15 sample people for each group and 30 people in total are selected, Blinding description: In order to control biases, evaluation of values is done by two people, independently and separately. The evaluators include two experienced orthotists, apart from the researcher, who use the Digimizer software (Digimizer, MedCalc Software, V.5.7.5, Belgium) to draw and measure the case. They perform the need on the digital image of each patient. In fact, each evaluator does his work without knowing which treatment group each patient is assigned to. This software is used for anthropometric measurements. The radiographic image of each patient at each stage is analyzed three times by each evaluator and with a minimum interval of one week between repeated measurements, by both evaluators and randomly. Each evaluator will be unaware of the measurements made by another person as well as his previous evaluation of the same graph, and finally the average measurement of each evaluator will be recorded for each person. It should be noted that in order to match the measurement method of both evaluators as much as possible, before starting the evaluations, the reproducibility between the two evaluators is checked. In this way, ten numbers of radiographic images are given to each evaluator in a similar way, and if there is no significant difference between the numbers reported by the two evaluators, they start the measurements related to the study. 4 Scoliosis. Intervention 1: Intervention group: Cheneau Brace made using targeted framework and 3D scanning and design technology. Intervention 2: Control group: Cheneau brace made in the conventional method. Yes - There is a plan to make this available What will be shared: Part of the data, such as the type and degree of deformity of the participants When: The access period starts 6 months after the results are published To whom: Only researchers working in university and scientific institutions Conditions: Only judges Where to obtain: To the project manager or researcher How to obtain: It will be available to them without any problem Comments: No problem
public Davood Farahmandi najafabadi
No.2, satar Ave.,shariati Ave.
Najafabad Iran (Islamic Republic of) 8513838413 +98 31 4263 3389 D.farahmandi@rehab.mui.ac.ir Esfahan University of Medical Sciences scientific hossien asyaie mehr
Hezarjarib Ave., Faculty of Rehabilitation, Isfahan city
Isfahan Iran (Islamic Republic of) 817463461 +98 31 3792 5006 asiyaeimehr@rehab.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Risser sign between 0 and 2 Major curvature in the thoracolumbar or lumbar region The curvature between 20 and 45 degrees No history of surgery, trauma or fracture Do not be overweight Did not used braces or other treatment methods before entering the study Do not have heart or respiratory disease 10 years 14 years Female Rehabilitation Rehabilitation Intervention group: Cheneau Brace made using targeted framework and 3D scanning and design technology Control group: Cheneau brace made in the conventional method Cobb's angle: In general, the apex of any curve is the farthest vertebra from the central vertical sacral line with it. The top and bottom end beads in each curve define the boundaries of that particular curve. Cobb's angle is an index used to quantitatively evaluate the lateral deviation of the spine in the frontal plane and is usually known as the gold standard for diagnosing and evaluating the severity and predicting the progression of the deviation in scoliosis patients. Timepoint: In both the control and experimental groups, each subject will have three radiological photographs in a standing position from two anterior-posterior and lateral views. Once before receiving the brace, when the brace is prescribed and the patient is prepared for casting or scanning. 20 days after the patient adapts to the orthosis, while the patient wears the brace, radiology imaging is done. The third imaging of the entire spine, without orthosis, is done for the long-term evaluation of the progress of the curve, with an interval of 6 months from the beginning. Method of measurement: To measure the angle of the spine, the patient's spine should be taken with an anterior-posterior view while standing in a normal position. Apical vertebral rotation: Vertebral rotation takes place in the transverse plane. The amount of rotation of the vertebrae is of key importance in the prognosis of the disease and the effect of orthotic treatment or other interventions. The highest rotation is related to the vertex. Examining the rotation of the vertebral column around its longitudinal axis is an essential parameter in the study of adolescent idiopathic scoliosis. Timepoint: In both the control and experimental groups, each subject will have three radiological photographs in a standing position from two anterior-posterior and lateral views. Once before receiving the brace, when the brace is prescribed and the patient is prepared for casting or scanning. 20 days after the patient adapts to the orthosis, while the patient wears the brace, radiology imaging is done. The third imaging of the entire spine, without orthosis, is done for the long-term evaluation of the progress of the curve, with an interval of 6 months from the beginning. Method of measurement: Apical vertebral rotation: To measure the amount of rotation of the vertebra, the Nash & Moe method is used, which has acceptable validity and reliability. In this method, five degrees are introduced for the rotation of the vertex. Kyphosis and lordosis: Kyphosis and lordosis, respectively, refer to an anterior and posterior concavity of the spine in the sagittal plane, caused by the shape of the vertebral bodies and intervertebral discs. Timepoint: Each subject will have three radiological photographs in standing position from two anterior-posterior and lateral views. Once before receiving the brace, when the brace is prescribed and the patient is prepared for casting or scanning. 20 days after the patient adapts to the orthosis, while the patient wears the brace, radiology imaging is done. The third imaging of the whole spine, without orthosis, is done for long-term evaluation of curve progress, with an interval of 6 months from the beginning. Method of measurement: By measuring Cobb's angle, kyphosis and lordosis in teenagers, it is in the normal range between 20 to 40 and 35 to 60 degrees, respectively. Behsaz Teb Ajand Knowledge Base Company Approved 2023-11-05 Ethics committee of Isfahan University of Medical Sciences No. 2, Khordad Str., Sattar Ave., Shariati Blvd., Najafabad City Najafabad Isfehan Iran (Islamic Republic of)