Evaluation of the immediate effect of designed thoracolumbosacral braces on curvature correction in patients with juvenile idiopathic scoliosis
Design
The study design will be performed as a clinical trial without control group, single group, non-blind, non-random, on 5 patients.
Settings and conduct
The study site is the radiology centers of Isfahan University of Medical Sciences. The immediate effect of curvature correction by a researcher-designed brace on patients is measured. In order to evaluate the immediate effect of orthosis, first a radiograph of the patient's spine (5 patients in a group) is taken in a standing position and the angle of curvature of the spine is determined by tapping method, then the patient wears the brace full time for one The moon is covered and the amount of recurrence is calculated after one month in the standing position on the frontal plate while the patient is wearing the brace.
Participants/Inclusion and exclusion criteria
The age range of participants is between 10 and 14 years; The racer mark of the participants is between 0 and 2; The initial curvature of the participants is between 25 and 45 degrees; the apex of the scoliotic curvature is below the fifth thoracic vertebra; Participants have not reached skeletal maturity or one year has passed since their maturity.
Intervention groups
Intervention group: Patients will wear braces full time (23 hours a day) for one month, and then the size of the curvature will be calculated before the intervention, and again after a month standing on the frontal plate while the patient wore the brace.
Main outcome variables
angle of curvature of the spine.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200516047459N6
Registration date:2022-01-09, 1400/10/19
Registration timing:registered_while_recruiting
Last update:2022-01-09, 1400/10/19
Update count:0
Registration date
2022-01-09, 1400/10/19
Registrant information
Name
Masoud Rafiaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5043
Email address
ma.rafiaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-16, 1400/09/25
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of immediate effect of designed brace on curve correction of adolescent idiopathic scoliosis
Public title
The effect of spinal orthosis on spinal deviation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age range of participants is between 10 and 14 years.
Racer mark of participants should be between 0 and 2,
The initial curvature of the participants should be between 25 and 45 degrees,
The apex of the scoliosis curve is below the fifth thoracic vertebra;
Exclusion criteria:
Participants have reached skeletal maturity or more than one year has passed since their maturity.
Age
From 10 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
No.318 ,Rehabilitation college, Isfahan University and medical sciences, Hezar Jerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-11-13, 1400/08/22
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.181
Health conditions studied
1
Description of health condition studied
scoliosis
ICD-10 code
M41.115
ICD-10 code description
Juvenile idiopathic scoliosis, thoracolumbar region
Primary outcomes
1
Description
The size of the spine curvature that will be taken through the photograph by estimating the cobb angle.
Timepoint
Before, Immediately after and one month after wearing the brace
Method of measurement
In order to evaluate the immediate effect of orthosis, a radiograph of the patient's spine is first taken standing and the angle of curvature of the spine is determined by a percussion method.
Secondary outcomes
1
Description
Angle of curvature of the spine
Timepoint
Before, immediately after and a month later
Method of measurement
Evaluate the angle of curvature using graphic photography
Intervention groups
1
Description
Intervention group (spine brace): In the first stage, the CT scan data of 5 people with scoliosis who have already had a CT scan at the request of a doctor and whose information is available in radiology centers, will be used for 3D modeling of the finite element, then design The optimal brace will be based on the 3D model made. After determining the optimal model of load application, this optimal model will be used in the second phase of the study in the treatment of braces of 5 people with juvenile idiopathic scoliosis. Then the patient wears the braces full time (23 hours a day) for one month and The amount of recurrence curve is calculated after one month of standing on the frontal plate while the patient is wearing a brace.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Masoud Rafiaei
Street address
No.318 ,Rehabilitation college, Isfahan University and medical sciences, Hezar Jerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Street address
No.318 ,Rehabilitation college, Isfahan University and medical sciences, Hezar Jerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.com
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
20
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
Masoud Rafiaei
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
No.318 ,Rehabilitation college, Isfahan University and medical sciences, Hezar Jerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
No.318 ,Rehabilitation college, Isfahan University and medical sciences, Hezar Jerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
No.318 ,Rehabilitation college, Isfahan University and medical sciences, Hezar Jerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Documents and information about the participants are confidential.