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IRCT20180918041062N1 IRCT 2019-02-27 Iran University of Medical Sciences Designing and manufacturing a new brace, based on trunk asymmetry and considering the efficacy on spine lateral deformation and trunk symmetry in adolescent idiopathic scoliosis Designing and manufacturing a new brace, based on trunk asymmetry and pad pressure optimization and considering the efficacy on Cobb angle and trunk symmetry in adolescent idiopathic scoliosis 2019-01-21 anticipated 10 Complete https://irct.ir/trial/35674 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: All volunteers deliver a brace and are unknown of the difference in brace mechanism. they are not in the same place. 2-3 Adolescent idiopathic scoliosis. Intervention 1: Intervention group: in intervention group, new brace will be designed and manufactured based on trunk asymmetry, using 3 dimensional requisition. in this group, prominent area of one half of body than other half, is considered as the area of pad pressure applying. New brace includes unpredictable number of pads. number and trim line of pads is determined according the pattern of trunk asymmetry. pads are made from polypropylene 4 millimeter sheets. brace includes two anterior and posterior uprights. pads in posterior, are connected to posterior upright and in anterior, are connected to anterior upright by using hook and loop. Intervention 2: Control group: conventional brace treatment group, don't change the routine treatment approach. in this group, brace is designed and manufactured according to routine protocol using manual casting method. In conventional protocol, brace can be a cervico-thoraco-lumbo-sacral(CTLSO) or thoraco-lumbo-sacral(TLSO). Conventional prescribed brace is a TLSO Boston or CTLSO Milwaukee brace. Yes - There is a plan to make this available What will be shared: Participants data file (IPD): All data after being unrecognizable, will be published. Study protocol will be published clearly. Statistical analysis plan will be published Report of clinical study will be published completely. When: Starting time of accessibility to these information, would be after the end of study and publishing the result. It is expected this time would be at the start of 1399 (2020). Time duration of accessibility is unlimited. To whom: All people including researchers and clinicians can send a request for articles from this project. Only researchers who wants to do a meta analysis study, can send a request for documents. Conditions: Researchers can use documents only in meta analysis studies, provided that cite the original article. Where to obtain: Shahrbanoo Bidari tel: 00989399254668 Email: bidarish.to12@gmail.com Mojtaba Kamyab Email: mojtaba.kamyab@gmail.com How to obtain: Individual must send a request to mentioned email address. The request will be considered, if the person be eligible, documents will be sent. Comments:
public Shahrbanoo Bidari
Faculty of Rehabilitation Sciences, Madadkaran Allay, Shahnazari St., Madar Sq., Mirdamad Blvd.
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 7124 bidarish.to12@gmail.com Iran University of Medical Sciences scientific Mojtaba Kamyab
Faculty of rehabilitation sciences, Madadkaran Allay, Shahnazari st., Madar sq., Mirdamad blvd.
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 7124 mojtaba.kamyab@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) adolescents with idiopathic scoliosis higher than 25 degree who prescribed a spinal brace. Age of at least 10 year old when brace prescription 0-2 risser sign when starting treatment Before menarche or less than one year after starting menarche in girls 10 years 18 years Both Musculo-skeletal disorder A history of treatment Perceptual disorder Skin disease Respiratory disorder M41.1 Juvenile and adolescent idiopathic scoliosis Treatment - Devices Treatment - Devices Intervention group: in intervention group, new brace will be designed and manufactured based on trunk asymmetry, using 3 dimensional requisition. in this group, prominent area of one half of body than other half, is considered as the area of pad pressure applying. New brace includes unpredictable number of pads. number and trim line of pads is determined according the pattern of trunk asymmetry. pads are made from polypropylene 4 millimeter sheets. brace includes two anterior and posterior uprights. pads in posterior, are connected to posterior upright and in anterior, are connected to anterior upright by using hook and loop. Control group: conventional brace treatment group, don't change the routine treatment approach. in this group, brace is designed and manufactured according to routine protocol using manual casting method. In conventional protocol, brace can be a cervico-thoraco-lumbo-sacral(CTLSO) or thoraco-lumbo-sacral(TLSO). Conventional prescribed brace is a TLSO Boston or CTLSO Milwaukee brace. Curve correction: Is described as the amount of curve reduction after brace wearing. Timepoint: 2.5 month after brace wearing. Method of measurement: Cobb method, radiography. Appearance symmetry index: Is a criteria to judge about the similarity and symmetry of two half of body. Timepoint: 2.5 month after brace using. Method of measurement: Area symmetry index, Profile symmetry index. Rib cage deformity: Is described as any deformation in rib cage, which occurs after scoliosis. Timepoint: 2.5 month after brace using. Method of measurement: Vertebro-costal angle, Lateral trunk shift, Thoracic ratio index, Rib index. Trunk deformation perception: Is described as individual perception of trunk appearance regarding amount of symmetry. Timepoint: 2.5 month after brace using. Method of measurement: Trunk appearance perception scale. Patient satisfaction: Patient satisfaction is a measure of the extent to which a patient is content with the health care which they received from their health care provider. Timepoint: 2.5 month after brace using. Method of measurement: Patient satisfaction questionnaire. Iran University of Medical Sciences Approved 2018-11-12 Ethics committee of Iran University of Medical Sciences Madadkaran allay., Shahnazari st., Mohseni sq., Mirdamad blvd, Tehran Tehran Iran (Islamic Republic of)