Protocol summary
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Study aim
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Studying the effect of Kyphologic and Maria Adelaide Orthoses on the Sagittal Spinal Curves in people with Scheuermann’s Kyphosis
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Design
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The study is a randomized clinical trial with parallel groups (intervention and control). A total of 10 samples are selected based on previous studies. The samples are randomly divided into two equal groups using the kyphological orthosis and Maria Adelaide orthosis users.
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Settings and conduct
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Participating people are selected from among the clients to the Orthotics and Prosthetics Clinics of Isfahan and Yazd Universities of Medical Sciences and Royesh technical orthopedic clinic based on the entry and exit criteria. X-rays are taken of the patient's spine in a standing position. Both orthoses are custom-made. Molding, modification of the positive mold of orthosis is done.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: The kyphosis angle of the thoracic or thoracolumbar region should be more than 45 and less than 75 degrees؛ The Risser sign is between zero and two؛ The apex of the arch is at T7 or lower؛ There is no contraindication for using a brace.
Exclusion criteria: Body mass index is more than 30؛ In addition to kyphosis, have scoliosis؛ Have musculoskeletal, neurological or metabolic diseases at the same time؛ Deformity of the spine is congenital. Have previously undergone spine surgery.
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Intervention groups
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The test group will receive the kyphologic orthosis and the control group will receive the Maria Adelaide orthosis.
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Main outcome variables
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Cervical Lordosis؛ Lumbar Lordosis؛ Thoracic Kyphosis؛ Cervical Sagittal Line؛ Sacral Inclination Angle؛ Pelvic Tilt
General information
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Reason for update
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corrections in Second recruitment center
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20241013063348N1
Registration date:
2024-12-04, 1403/09/14
Registration timing:
prospective
Last update:
2025-06-29, 1404/04/08
Update count:
1
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Registration date
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2024-12-04, 1403/09/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-12-20, 1403/09/30
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Expected recruitment end date
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2025-12-21, 1404/09/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Studying the effect of Kyphologic and Maria Adelaide Orthoses on the Sagittal Spinal Curves in people with Scheuermann’s Kyphosis: a randomized clinical trial
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Public title
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Studying the effect of Kyphologic and Maria Adelaide Orthoses on the Sagittal Spinal Curves
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 8 years old to 16 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
10
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-10-07, 1403/07/16
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Ethics committee reference number
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IR.MUI.NUREMA.REC.1403.112
Health conditions studied
1
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Description of health condition studied
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Scheuermann’s Kyphosis
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Cervical Lordosis Angle
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Timepoint
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Before, one month and six months after the intervention
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Method of measurement
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EOS radiography device operator software
2
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Description
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Thoracic Kyphosis Angle
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Timepoint
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Before, one month and six months after the intervention
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Method of measurement
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EOS radiography device operator software
3
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Description
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Lumbar Lordosis Angle
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Timepoint
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Before, one month and six months after the intervention
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Method of measurement
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EOS radiography device operator software
4
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Description
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Sagittal Vertical Axis
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Timepoint
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Before, one month and six months after the intervention
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Method of measurement
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EOS radiography device operator software
5
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Description
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Sacral Inclination Angle
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Timepoint
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Before, one month and six months after the intervention
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Method of measurement
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EOS radiography device operator software
6
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Description
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Pelvic Tilt Angle
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Timepoint
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Before, one month and six months after the intervention
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Method of measurement
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EOS radiography device operator software
Secondary outcomes
1
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Description
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Satisfaction score
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Timepoint
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Six months after the intervention
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Method of measurement
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Questionnaire survey of orthosis and prosthesis users
Intervention groups
1
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Description
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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
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Category
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Treatment - Devices
2
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Description
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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.
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Study information other than individual information is shared with other researchers.
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When the data will become available and for how long
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Information will be shared after results or data summaries are shared.
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To whom data/document is available
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Information is shared for academic purposes only.
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Under which criteria data/document could be used
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Information is shared for the research and teaching of applicants.
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From where data/document is obtainable
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People can get the information from the responsible person.
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What processes are involved for a request to access data/document
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Applications must be sent via email. (sadeghi@rehab.mui.ac.ir)
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Comments
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