Designing and manufacturing a new brace, based on trunk asymmetry and pad pressure optimization and considering the efficacy on Cobb angle and trunk symmetry in adolescent idiopathic scoliosis
Designing and manufacturing a new brace, based on trunk asymmetry and pad pressure optimization and considering the efficacy on Cobb angle and trunk symmetry in adolescent idiopathic scoliosis
Design
volunteers will recruited in new brace and conventional brace groups. A pilot clinical trial , phase 2-3, single blind, parallel group. Sample size is 10 person, 5 subject in each group.
Settings and conduct
study will done in two major stage:
first stage includes brace designing according to asymmetry of two half of body. second stage includes comparing brace efficacy in two groups.
brace designing is done in four steps of creating best plane of symmetry, creating asymmetry map, rectifying the 3 dimensional trunk image and brace manufacturing using computer carving.
In the second phase, subjects will compared in two groups of new brace and conventional brace.
project will be done in a private clinic and faculty of rehabilitation of Iran university of medical sciences.
patients are blinded of any difference in the brace mechanism.
Participants/Inclusion and exclusion criteria
Inclusion: Adolescents with idiopathic scoliosis higher than 25 degree who prescribed a spine brace
At least 10 years old when prescribing a brace
0-2 risser sign when starting brace treatment
Before menarche or less than one year after starting menarche in girls
Non-inclusion:
Musculo-skeletal disorder
A history of treatment
Perceptual disorder
Skin disease
Respiratory disorder
Intervention groups
Treatment group will receive new brace according to body asymmetry
conventional brace group: will receive Boston or Milwaukee brace.
Designing and manufacturing a new brace, based on trunk asymmetry and pad pressure optimization and considering the efficacy on Cobb angle and trunk symmetry in adolescent idiopathic scoliosis
Public title
Designing and manufacturing a new brace, based on trunk asymmetry and considering the efficacy on spine lateral deformation and trunk symmetry in adolescent idiopathic scoliosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
adolescents with idiopathic scoliosis higher than 25 degree who prescribed a spinal brace.
Age of at least 10 year old when brace prescription
0-2 risser sign when starting treatment
Before menarche or less than one year after starting menarche in girls
Exclusion criteria:
Musculo-skeletal disorder
A history of treatment
Perceptual disorder
Skin disease
Respiratory disorder
Age
From 10 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
All volunteers deliver a brace and are unknown of the difference in brace mechanism. they are not in the same place.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Curve correction: Is described as the amount of curve reduction after brace wearing.
Timepoint
2.5 month after brace wearing
Method of measurement
Cobb method, radiography
Secondary outcomes
1
Description
Appearance symmetry index: Is a criteria to judge about the similarity and symmetry of two half of body
Timepoint
2.5 month after brace using
Method of measurement
Area symmetry index, Profile symmetry index
2
Description
Rib cage deformity: Is described as any deformation in rib cage, which occurs after scoliosis.
Timepoint
2.5 month after brace using
Method of measurement
Vertebro-costal angle, Lateral trunk shift, Thoracic ratio index, Rib index
3
Description
Trunk deformation perception: Is described as individual perception of trunk appearance regarding amount of symmetry.
Timepoint
2.5 month after brace using
Method of measurement
Trunk appearance perception scale
4
Description
Patient satisfaction: Patient satisfaction is a measure of the extent to which a patient is content with the health care which they received from their health care provider.
Timepoint
2.5 month after brace using
Method of measurement
Patient satisfaction questionnaire
Intervention groups
1
Description
Intervention group: in intervention group, new brace will be designed and manufactured based on trunk asymmetry, using 3 dimensional requisition. in this group, prominent area of one half of body than other half, is considered as the area of pad pressure applying. New brace includes unpredictable number of pads. number and trim line of pads is determined according the pattern of trunk asymmetry. pads are made from polypropylene 4 millimeter sheets. brace includes two anterior and posterior uprights. pads in posterior, are connected to posterior upright and in anterior, are connected to anterior upright by using hook and loop.
Category
Treatment - Devices
2
Description
Control group: conventional brace treatment group, don't change the routine treatment approach. in this group, brace is designed and manufactured according to routine protocol using manual casting method. In conventional protocol, brace can be a cervico-thoraco-lumbo-sacral(CTLSO) or thoraco-lumbo-sacral(TLSO). Conventional prescribed brace is a TLSO Boston or CTLSO Milwaukee brace.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran university of medical sciences
Full name of responsible person
Hassan Ghandehari
Street address
Mojahedine eslam st., Shafa Hospital
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 3354 2001
Email
spineiran@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malekooti
Street address
Iran University of Medical Sciences, Hemmat high way
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Participants data file (IPD): All data after being unrecognizable, will be published.
Study protocol will be published clearly.
Statistical analysis plan will be published
Report of clinical study will be published completely.
When the data will become available and for how long
Starting time of accessibility to these information, would be after the end of study and publishing the result. It is expected this time would be at the start of 1399 (2020). Time duration of accessibility is unlimited.
To whom data/document is available
All people including researchers and clinicians can send a request for articles from this project.
Only researchers who wants to do a meta analysis study, can send a request for documents.
Under which criteria data/document could be used
Researchers can use documents only in meta analysis studies, provided that cite the original article.