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IRCT20220330054371N1 IRCT 2022-05-09 Esfahan University of Medical Sciences The effectiveness of bracing with home-based exercise aids on spinal deformity of life in adolescents idiopathic scoliosis The effectiveness of bracing with home-based exercise aids on spinal deformity, pulmonary function, trunk muscle endurance and quality of life in adolescents idiopathic scoliosis: A parallel-groups clinical study 2022-07-06 anticipated 16 Complete https://irct.ir/trial/62811 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the samples are placed in a block randomization method with the aim of entering equal samples in each group. The method of random appointment in both groups is that the size of each block is 4 people and based on this and considering the two test groups (T) and control group (C), 6 blocks are obtained. The arrangement of the members of each block is (TTCC), (TCCT), (TCTC), (CCTT), (CTTC) and (CTCT). The blocks are randomly selected and individuals receive the desired treatment based on the order of inclusion criteria in the study, Blinding description: The measurement of curve angle will be carried out using blind assessors. The assessors will measure the curve angle while they are unaware of group allocations and personal details. N/A Lateral spinal deviation with idiopathic cause in adolescents in thoracolumbar and lumbar region. Intervention 1: Intervention group: Combination of brace and home-based exercise aid, Cheanue brace: Cheanue is a short piece of thoracolumbosacral brace, made of polypropylene, which opens and closes from the front. By conveying a load on the convex side, the brace directs the spine to the large valves on the wall in all three planes of motion, allowing the patient to perform therapeutic exercises for at least one hour a day. Braces are made specifically by molding the patient's spine. Cantilever Device: A rigid framework consists of levers that increase the mechanical advantage of the device by increasing its length. The corrective mechanism of the system is three points of pressure in which it is done by applying transverse load by pads to the spine to achieve a reduction in deviation. The pads in the device are made of polyurethane and its size depends on the size of the patient. The thoracic pad is fitted on the convex side of the deflection and on the gear that is articulated to the vertex of the deflection and its lower gear. The lumbar pad is also placed between the lower ribs and the upper iliac crest. Intervention 2: Control group: Use braces and scoliosis exercise program at home. Cheanue brace: Cheanue is a short piece of thoracolumbosacral brace, made of polypropylene, which opens and closes from the front. By conveying a load on the convex side, the brace directs the spine to the large valves on the wall in all three planes of motion, allowing the patient to perform therapeutic exercises for at least one hour a day. Braces are made specifically by molding the patient's spine. scoliosis exercise program at home: The exercises in the control group are designed for patients by a therapist and the patient is taught how and when to perform and repeat the exercises orally and in the form of a logbook. Yes - There is a plan to make this available What will be shared: Study information (other than personal information) is shared with other researchers. When: Information is shared after the results are printed or summarized. To whom: Information will be shared for academic purposes only. Conditions: Information is shared to teach and research applicants. Dr. Sadeghi (Executive Officer) will review the applications. Where to obtain: Individuals can request information from the responsible person introduced. How to obtain: Requests must be sent via email (sadeghi@rehab.mui.ac.ir). Comments:
public Dr. Ebrahim Sadeghi Demneh
School of Rehabilitation, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5053 sadeghi@rehab.mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Ebrahim Sadeghi Demneh
School of Rehabilitation, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5053 sadeghi@rehab.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Diagnosis of idiopathic scoliosis by a specialist Risser sign 0-2 Thoracolumbar or lumbar curve 20-45 degrees Single or C-type curves Ability to use of braces and home-based exercise aids Physician approval to participate in research 11 years 17 years Both Existence of shortness and defects in the lower extremities People with underlying neuromuscular diseases such as cerebral palsy, spina bifida, muscular dystrophy, congenital myopathy and any other disease that is not able to exercise People with any history of surgery, trauma, fractures and other injuries to the spine M41.125 Adolescent idiopathic scoliosis, thoracolumbar region Treatment - Devices Treatment - Devices Intervention group: Combination of brace and home-based exercise aid, Cheanue brace: Cheanue is a short piece of thoracolumbosacral brace, made of polypropylene, which opens and closes from the front. By conveying a load on the convex side, the brace directs the spine to the large valves on the wall in all three planes of motion, allowing the patient to perform therapeutic exercises for at least one hour a day. Braces are made specifically by molding the patient's spine. Cantilever Device: A rigid framework consists of levers that increase the mechanical advantage of the device by increasing its length. The corrective mechanism of the system is three points of pressure in which it is done by applying transverse load by pads to the spine to achieve a reduction in deviation. The pads in the device are made of polyurethane and its size depends on the size of the patient. The thoracic pad is fitted on the convex side of the deflection and on the gear that is articulated to the vertex of the deflection and its lower gear. The lumbar pad is also placed between the lower ribs and the upper iliac crest. Control group: Use braces and scoliosis exercise program at home. Cheanue brace: Cheanue is a short piece of thoracolumbosacral brace, made of polypropylene, which opens and closes from the front. By conveying a load on the convex side, the brace directs the spine to the large valves on the wall in all three planes of motion, allowing the patient to perform therapeutic exercises for at least one hour a day. Braces are made specifically by molding the patient's spine. scoliosis exercise program at home: The exercises in the control group are designed for patients by a therapist and the patient is taught how and when to perform and repeat the exercises orally and in the form of a logbook. The amount of Cobb angle in the spine. Timepoint: This variable is measured in two sessions. The first time, the measurement is done in the pre-test stage (before the intervention). Then we ask the person to use braces and exercises for three months. After three months, the relevant variable is measured for the second time in the post-test phase. Method of measurement: To measure the angle of the cobb, the patient's spine with anterior-posterior view is used while standing in a normal position. The calculation is done manually with the help of a pencil and a conveyor. Cobb angle is the angle created between two lines perpendicular to the upper plateau of the upper vertebra of the scoliotic deviation and the line perpendicular to the lower plateau of the lower vertebra of the scoliotic deviation. On the other hand, because the intersection point is often somewhere off the page, an alternative method is used. Draw a right perpendicular to the two tangent lines and the angle created by the intersection of the two perpendicular lines is the angle of the cobb. Evaluation of pulmonary function. Timepoint: This variable is measured in two sessions. The first time, the measurement is done in the pre-test stage (before the intervention). Then we ask the person to use braces and exercises for three months. After three months, the relevant variable is measured for the second time in the post-test phase. Method of measurement: Pulmonary function will be assessed by spirometry test using a Japanese CHESTGRAPH HI-301 digital spirometer. After giving personal information to the device and calibrating it, the tests of Total Lung Capacity, Vital Capacity, Forced Vital Capacity, Vital Capacity Inspiratory , Vital Capacity Expiratory, Peak Expiratory Flow and Forced Expiratory Volume In One Second , respectively. This test is performed while sitting on a chair and the patient is asked to remove the brace at least 2 hours before the test. To measure spirometric Indicators, a person is first asked to perform a normal inspiration. The mouthpiece of the device is immediately placed in his mouth and he takes a deep Expiration. The person then takes a deep inspiration, takes a deep Expiration, and then a deep inspiration, and the experiment ends at the end of this deep inspiration. During the test, care will be taken not to separate the input of the device from the mouth. Also, there should be no interruption between her inspiration and Expiration, and the duration of a deep Expiration should last at least 6 seconds. The alarm device alarm will be used for sufficient air. The endurance of the trunk muscles. Timepoint: This variable is measured in two sessions. The first time, the measurement is done in the pre-test stage (before the intervention). Then we ask the person to use braces and exercises for three months. After three months, the relevant variable is measured for the second time in the post-test phase. Method of measurement: Trunk muscle endurance is assessed by lumbar trunk endurance test or LTMET to assess flexor and extensor trunk endurance and Side-Bridge test to assess lateral trunk flexor endurance. Finally, the Time (s) of Maintain position for each test in both groups can be recorded and compared. Quality of life index. Timepoint: This variable is measured in two sessions. The first time, the measurement is done in the pre-test stage (before the intervention). Then we ask the person to use braces and exercises for three months. After three months, the relevant variable is measured for the second time in the post-test phase. Method of measurement: Quality of life index is measured by ISYQOL questionnaire which has 13 questions in the field of spinal health. The answers to the questions are based on a 3-point scale (zero to 2) in 3 options (never, sometimes, often). Thus, the score of each question will be between 0 and 2 and the range of total numerical scores will be between 0 and 26 for spinal health. That is, the number zero will be the highest quality of life and the number 26 will be the lowest level of quality of life. Esfahan University of Medical Sciences Approved 2022-04-24 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan Isfahan Isfehan Iran (Islamic Republic of)