Studying the effect of Kyphologic and Maria Adelaide Orthoses on the Sagittal Spinal Curves in people with Scheuermann’s Kyphosis: a randomized clinical trial
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 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.
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
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)