Determining the degree of movement immobilization of two braces for proper prescription
Design
Eligible men will be identified by the student through a public announcement in the city of Isfahan (invitation to cooperation poster) and if they wish to participate in the study, they will be invited to Isfahan University of Medical Sciences, Faculty of Rehabilitation, Musculoskeletal Research Center. This project has three phases: 1- implementation of the plan and sampling 2- data analysis 3- thesis writing. This study is double-blind, and both the researcher and the subject are blind
Settings and conduct
Using a 3D motion analysis device and three markers, we check the cervical range of motion before and after wearing two rigid and foam Minerva braces. This study is conducted in the Isfahan Faculty of Rehabilitation of Medical Sciences
Participants/Inclusion and exclusion criteria
1- Men between 18 and 40 years old, due to the changes in the movement of the cervical vertebrae during growth and the increase in the prevalence of joint disorders in the neck area in older ages, can affect the range of motion in this area.
2- Cervical vertebrae should have no history of previous injury
Exclusion criteria (based on self-report):
1- The existence of any systematic skin or skeletal damage that makes it impossible to wear a brace
2- Presence of pain, muscle spasms, arthritis, neurological disease, and any history of round surgery
Intervention groups
In this study, a group of men is used in order to know the immobility of the brace before and after the intervention
Main outcome variables
type of brace
Extension cervical range of motion
Flexion cervical range of motion
Axial rotation cervical range of motion
Lateral Extension cervical range of motion
Age
Weight
height
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221129056658N1
Registration date:2022-12-07, 1401/09/16
Registration timing:prospective
Last update:2022-12-07, 1401/09/16
Update count:0
Registration date
2022-12-07, 1401/09/16
Registrant information
Name
Iran Khalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3277 0595
Email address
o.stufan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-11, 1401/09/20
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of foam and rigid minerva braces in cervical spine movements
Public title
Minerva immobilization
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
men 40 to 18 ages
Cervical vertebrae without a history of previous injury
Exclusion criteria:
Absence of pain, muscle spasm, arthritis, neurological disease and any history of neck surgery
Absence of systematic skin or skeletal damage that makes it possible to wear a brace
Age
From 18 years old to 40 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
29
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Efahan University of Medical Sciences
Street address
Hezargerib Blvd., Esfahan city., Esfahan university of medical science
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-08-20, 1401/05/29
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.063
Health conditions studied
1
Description of health condition studied
Healthy people
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The primary message is the range of motion of the neck
Timepoint
The immediate effect of wearing the first brace is checked, and the immediate effect of the second brace is checked thirty minutes after the first brace on the same day
Method of measurement
he range of motion of the neck is measured in degrees by a three-dimensional motion analysis device. This device follows the movements of night vision markers by shining infrared rays on them and measures the angles.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: rigid brace: The Minerva used in this research is a one-size adult Minerva manufactured by Kia Medical Company, which consists of two body shells in the front and back of the thorax.
Category
Treatment - Devices
2
Description
Intervention group: The second intervention is performed on the same group after thirty . Foam brace: This brace is very similar to Yale brace. Yale's original brace is a lightweight brace used to stabilize the cervical spine, this brace is a kind of long polypropylene load-bearing philadelphia that extends anteriorly and posteriorly to the thoracic region, and an anterior chest strap. and makes the rear. links to In Minerva foam brace, there are changes compared to Yale brace, in that the back support part is longer and a forehead strap is added to it. The inside of the polypropylene is covered with foam. This brace is made by Pouyan Mehr clinic.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazar Jarib Street, Isfahan University of Medical Sciences and Health Services, Faculty of Rehabilit
Full name of responsible person
Hossein AsiaiMehr
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences and Health Services, Faculty of Rehabilitation Sciences
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3669 3089
Email
O.stufan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Building No. 4, Research and Technology Vice-Chancellor
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
research@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
Hossein Asiaimehr
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthosis Prosthetic
Street address
Hazarjarib Street, Isfahan University of Medical Sciences and Health Services, Faculty of Rehabilitation Sciences
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5081
Email
asiyaeimehr@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Asiaimeher
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthosis and prosthesis
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences and Health Services, Faculty of Rehabilitation Sciences
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5081
Email
asiyaeimehr@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Asiaimehr
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthosis and prosthesis
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences and Health Services, Faculty of Rehabilitation Sciences
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5081
Email
asiyaeimehr@gmail.com
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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the studied data, such as degrees of neck movements, are published. the title is cervical range of motion
When the data will become available and for how long
The access starts two months after printing and the date of access is unlimited.
To whom data/document is available
The reduction effect of wearing a brace is measured in this study
Under which criteria data/document could be used
Analysis of the range of motion of the neck can be accessed by the software. Statistical analyzes can also be accessed
From where data/document is obtainable
09387324996 o.stufan@gmail.com Alireza Khalili
What processes are involved for a request to access data/document
nformation will be given after a call or email a week after the request