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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Protocol summary
Participating people are selected from among the clients to the Orthotics and Prosthetics Clinic of Isfahan University of Medical Sciences 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.
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.
Participating people are selected from among the clients to the Orthotics and Prosthetics ClinicClinics of Isfahan Universityand 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.
افراد شرکت کننده از بین مراجعین به کلینیک ارتوز و پروتز دانشگاه علوم پزشکی اصفهان بر اساس معیارهای ورود و خروج انتخاب می شوند. عکس رادیولوژی در حالت ایستاده از ستون فقرات بیمار 'گرفته می شود. هر دو ارتوز به روش سفارشی ساخت و طی مراحل قالبگیری و اصلاح قالب پوزیتیو، ساخته می شوند.
افراد شرکت کننده از بین مراجعین به کلینیک ارتوز و پروتز دانشگاههای علوم پزشکی اصفهان و یزد و ارتوپدی فنی رویش یزد بر اساس معیارهای ورود و خروج انتخاب می شوند. عکس رادیولوژی در حالت ایستاده از ستون فقرات بیمار 'گرفته می شود. هر دو ارتوز به روش سفارشی ساخت و طی مراحل قالبگیری و اصلاح قالب پوزیتیو، ساخته می شوند.
افراد شرکت کننده از بین مراجعین به کلینیک ارتوز و پروتز دانشگاهدانشگاههای علوم پزشکی اصفهان و یزد و ارتوپدی فنی رویش یزد بر اساس معیارهای ورود و خروج انتخاب می شوند. عکس رادیولوژی در حالت ایستاده از ستون فقرات بیمار 'گرفته می شود. هر دو ارتوز به روش سفارشی ساخت و طی مراحل قالبگیری و اصلاح قالب پوزیتیو، ساخته می شوند.
General information
empty
corrections in Second recruitment center
corrections in Second recruitment center
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اصلاحاتی در مرکز دوم نمونه گیری
اصلاحاتی در مرکز دوم نمونه گیری
Recruitment centers
#1
Name of recruitment center - English: Orthosis and Prosthesis Clinic, Faculty of Rehabilitation, Isfahan University of Medical Sciences
Name of recruitment center - Persian: کلینیک ارتوز پروتز دانشکده توانبخشی دانشگاه علوم پزشکی اصفهان
Full name of responsible person - English: Dr. Ebrahim Sadeghi
Full name of responsible person - Persian: دکتر ابراهیم صادقی
Street address - English: Hezar Jarib St
Street address - Persian: خیابان هزار جریب
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81746-73461
Phone: +98 31 3792 5096
Fax: +98 31 3669 3089
Email: sadeghi@rehab.mui.ac.ir
Web page address: https://mui.ac.ir
Name of recruitment center - English: Orthosis and Prosthesis Clinic, Faculty of Rehabilitation, Isfahan University of Medical Sciences
Name of recruitment center - Persian: کلینیک ارتوز پروتوز دانشگاه علوم پزشکی اصفهان
Full name of responsible person - English: Dr. Ebrahim Sadeghi
Full name of responsible person - Persian: دکتر ابراهیم صادقی
Street address - English: Hezar Jarib St
Street address - Persian: خیابان هزار جریب
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3792 5096
Fax: +98 31 3669 3089
Email: sadeghi@rehab.mui.ac.ir
Web page address: https://mui.ac.ir
Name of recruitment center - English: Orthosis and Prosthesis Clinic, Faculty of Rehabilitation, Isfahan University of Medical Sciences Name of recruitment center - Persian: کلینیک ارتوز پروتز دانشکده توانبخشیپروتوز دانشگاه علوم پزشکی اصفهان Full name of responsible person - English: Dr. Ebrahim Sadeghi Full name of responsible person - Persian: دکتر ابراهیم صادقی Street address - English: Hezar Jarib St Street address - Persian: خیابان هزار جریب City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81746-734618174673461 Phone: +98 31 3792 5096 Fax: +98 31 3669 3089 Email: sadeghi@rehab.mui.ac.ir Web page address: https://mui.ac.ir
#2
Name of recruitment center - English: Shahid Sadoughi University of Medical Sciences clinics, and Royesh technical orthopedi institute
Name of recruitment center - Persian: درمانگاههای دانشگاه علوم پزشکی شهید صدوقی یزد و موسسه ارتوپدی فنی رویش یزد
Full name of responsible person - English: Mahmoud Asayesh Zarchi
Full name of responsible person - Persian: محمود آسایش زارچی
Street address - English: Taleghani Blvd. Shahid daei 11 alley, deadend 11
Street address - Persian: بلوار طالقانی، کوچه 11 شهید داعی، بن بست 11
City - English: yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8913815359
Phone: +98 913 156 5652
Fax:
Email: toroyesh@gmail.com
Web page address:
Name of recruitment center - English: Shahid Sadoughi University of Medical Sciences clinics, and Royesh technical orthopedi institute Name of recruitment center - Persian: درمانگاههای دانشگاه علوم پزشکی شهید صدوقی یزد و موسسه ارتوپدی فنی رویش یزد Full name of responsible person - English: Mahmoud Asayesh Zarchi Full name of responsible person - Persian: محمود آسایش زارچی Street address - English: Taleghani Blvd. Shahid daei 11 alley, deadend 11 Street address - Persian: بلوار طالقانی، کوچه 11 شهید داعی، بن بست 11 City - English: yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 8913815359 Phone: +98 913 156 5652 Fax: Email: toroyesh@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Ebrahim Sadeghi
Full name of responsible person - Persian: دکتر ابراهیم صادقی
Street address - English: hezar jarib
Street address - Persian: هزار جریب
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81746-73461
Phone: +98 31 3668 0048
Fax: +98 31 3668 0048
Email: sadeghi@rehab.mui.ac.ir
Web page address: https://mui.ac.ir
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Gholamreza Asgari
Full name of responsible person - Persian: دکتر غلامرضا عسگری
Street address - English: Hezar Jarib
Street address - Persian: هزار جریب
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3668 7898
Fax: +98 31 3668 7898
Email: research@mui.ac.ir
Web page address: https://mui.ac.ir
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Ebrahim SadeghiGholamreza Asgari Full name of responsible person - Persian: دکتر ابراهیم صادقیغلامرضا عسگری Street address - English: hezar jaribHezar Jarib Street address - Persian: هزار جریب City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81746-734618174673461 Phone: +98 31 3668 00487898 Fax: +98 31 3668 00487898 Email: sadeghiresearch@rehab.mui.ac.irmui.ac.ir Web page address: https://mui.ac.ir
Protocol summary
Study aim
Studying the effect of Kyphologic and Maria Adelaide Orthoses on the Sagittal Spinal Curves in people with Scheuermann’s Kyphosis
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
The test group will receive the kyphologic orthosis and the control group will receive the Maria Adelaide orthosis.
Studying the effect of Kyphologic and Maria Adelaide Orthoses on the Sagittal Spinal Curves in people with Scheuermann’s Kyphosis: a randomized clinical trial
Public title
Studying the effect of Kyphologic and Maria Adelaide Orthoses on the Sagittal Spinal Curves
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 8 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Nursing, Management and Rehabilitation - Isfahan University of Medica
Street address
Hezar jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-10-07, 1403/07/16
Ethics committee reference number
IR.MUI.NUREMA.REC.1403.112
Health conditions studied
1
Description of health condition studied
Scheuermann’s Kyphosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cervical Lordosis Angle
Timepoint
Before, one month and six months after the intervention
Method of measurement
EOS radiography device operator software
2
Description
Thoracic Kyphosis Angle
Timepoint
Before, one month and six months after the intervention
Method of measurement
EOS radiography device operator software
3
Description
Lumbar Lordosis Angle
Timepoint
Before, one month and six months after the intervention
Method of measurement
EOS radiography device operator software
4
Description
Sagittal Vertical Axis
Timepoint
Before, one month and six months after the intervention
Method of measurement
EOS radiography device operator software
5
Description
Sacral Inclination Angle
Timepoint
Before, one month and six months after the intervention
Method of measurement
EOS radiography device operator software
6
Description
Pelvic Tilt Angle
Timepoint
Before, one month and six months after the intervention
Method of measurement
EOS radiography device operator software
Secondary outcomes
1
Description
Satisfaction score
Timepoint
Six months after the intervention
Method of measurement
Questionnaire survey of orthosis and prosthesis users
Intervention groups
1
Description
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
Category
Treatment - Devices
2
Description
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.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthosis and Prosthesis Clinic, Faculty of Rehabilitation, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Sadeghi
Street address
Hezar Jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5096
Fax
+98 31 3669 3089
Email
sadeghi@rehab.mui.ac.ir
Web page address
https://mui.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Sadoughi University of Medical Sciences clinics, and Royesh technical orthopedi institute
Full name of responsible person
Mahmoud Asayesh Zarchi
Street address
Taleghani Blvd. Shahid daei 11 alley, deadend 11
City
yazd
Province
Yazd
Postal code
8913815359
Phone
+98 913 156 5652
Email
toroyesh@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Fax
+98 31 3668 7898
Email
research@mui.ac.ir
Web page address
https://mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Sadeghi
Position
Professor and faculty member of the Department of Orthosis and Prosthetics, Faculty of Rehabilitatio
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5096
Fax
+98 31 3669 3089
Email
sadeghi@rehab.mui.ac.ir
Web page address
https://mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Sadeghi
Position
Professor and faculty member of the Department of Orthosis and Prosthetics, Faculty of Rehabilitatio
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5096
Fax
+98 31 3668 0048
Email
sadeghi@rehab.mui.ac.ir
Web page address
https://mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Sadeghi
Position
Professor and faculty member of the Department of Orthosis and Prosthetics, Faculty of Rehabilitatio
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5096
Fax
+98 31 3668 0048
Email
sadeghi@rehab.mui.ac.ir
Web page address
https://mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study information other than individual information is shared with other researchers.
When the data will become available and for how long
Information will be shared after results or data summaries are shared.
To whom data/document is available
Information is shared for academic purposes only.
Under which criteria data/document could be used
Information is shared for the research and teaching of applicants.
From where data/document is obtainable
People can get the information from the responsible person.
What processes are involved for a request to access data/document
Applications must be sent via email. (sadeghi@rehab.mui.ac.ir)