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Designing and Developing of Forward Head Rounded Shoulder posture corrective Orthosis (FHRSO) and its Immediate Effect on Craniovertebral and Protraction-Retraction angles in people with Postural deviations in upper body

Protocol summary

Study aim
Designing and Developing of Forward Head Rounded Shoulder posture corrective Orthosis (FHRSO) and its Immediate Effect on Craniovertebral and Protraction-Retraction angles in people with Postural deviations in upper body
Design
A single group with repeated measure design. The participants randomly assigned to the sequence of with orthosis and without orthosis conditions.
Settings and conduct
The measurement was performed with the digital camera, that it was set at a distance of 1.5 meter, on a tripod, all assessments were conducted by a orthotics and prosthesis expert who did not participate in the invention of mentioned orthotics. Photo was recorded in the standing position in the lateral view. after the photography , data entered into the Digimizer software and the angles were evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range 18 to 60 years old , and the angle of the craniovertebral less than 42/5 degrees. exclusion criteria: history of neck surgery, The history of neurological diseases, fractures in cervical vertebrae, scoliosis, rheumatic diseases, torticolli in neck, lack of balance in standing, neck pain, use of assistive device to hearing aids, congenital or bony abnormalities in neck vertebrae, systemic diseases such as arthritis, shoulder surgery history, history of any damage in the scapula and shoulder pain
Intervention groups
a single group with repeated measure design: with and without posture corrective orthosis
Main outcome variables
craniovertebral angle protraction-retraction angle

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200301046657N2
Registration date: 2020-05-06, 1399/02/17
Registration timing: registered_while_recruiting

Last update: 2020-05-06, 1399/02/17
Update count: 0
Registration date
2020-05-06, 1399/02/17
Registrant information
Name
Ali Khaghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0947
Email address
khaghani.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and Developing of Forward Head Rounded Shoulder posture corrective Orthosis (FHRSO) and its Immediate Effect on Craniovertebral and Protraction-Retraction angles in people with Postural deviations in upper body
Public title
The effectiveness of corrective posture orthotics on head and neck
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age range of 18 to 60 years The angle of the craniovertebral is less than 42.5 degrees.
Exclusion criteria:
history of neck surgery The history of neurological diseases fractures in cervical vertebrae scoliosis rheumatic diseases torticolli in neck lack of balance in standing neck pain , use of assistive device to hearing aids congenital or bony abnormalities in neck vertebrae systemic diseases such as arthritis shoulder surgery history history of any damage in the scapula and shoulder pain
Age
From 18 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
School of Rehabilitation Sciences, Madadkaran All., Shahnazari St., Madar Sq., Mirdamad Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
Approval date
2020-01-03, 1398/10/13
Ethics committee reference number
IR.IUMS.REC.1398.1021

Health conditions studied

1

Description of health condition studied
Forward head posture
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
protraction-retraction angle: the angle between the spinous process of C7 and the middle point of the humeral head and Horizontal line.
Timepoint
immediately effect
Method of measurement
The method of measuring the angles is photography with digital camera(Nikon D7000, Nikon Corporation, Japan) and method of calculating angles is with the Digimizer software( model 5.3.5 MedCalc Software )

2

Description
craniovertebral angle is the angle between ear Targus, the spinous process of C7 and the horizontal line.
Timepoint
immediately effect
Method of measurement
The method of measuring the angles is photography with digital camera(Nikon D7000, Nikon Corporation, Japan) and method of calculating angles is with the Digimizer software( model 5.3.5 MedCalc Software ).

Secondary outcomes

empty

Intervention groups

1

Description
In this study, using postural corrective orthosis, which is a assisstive device to adopt the correct posture, intervention is performed random with orthosis for 10 minutes, and the target angles are measured by phothography method.
Category
Treatment - Devices

2

Description
Intervention group: The target angles are measured by photography method random, without the use of postural corrective orthosis .
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation school of Iran University of Medical Sciences
Full name of responsible person
Reza Hamzelouei
Street address
Hashemi Alley-Shohada Square-Bonyad Blv
City
khomein
Province
Markazi
Postal code
3881917558
Phone
+98 86 4633 9228
Email
rezarh777@yahoo.com.sg

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Abbas Motevalian
Street address
5th Floor, Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Ali Khaghani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
School of Rehabilitation Sciences of Iran University of Medical Sciences, Shahnazari St., Mother Square, Mirdamad Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 2059
Email
khaghaniali@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Khaghani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
School of Rehabilitation Sciences of Iran University of Medical Sciences, Shahnazari St., Mother Square, Mirdamad Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
khaghaniali@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Hamzelouei
Position
MSC student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Bonyad Blv-Shohada Square-Hashemi Alley
City
Khomein
Province
Markazi
Postal code
3881917558
Phone
+98 86 4633 9228
Email
Rezarh777@yahoo.com.sg

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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only the statistical information for variable-identifiable individuals is reported.
When the data will become available and for how long
Six months after printing results
To whom data/document is available
Supervisor in Study
Under which criteria data/document could be used
Do not publish identity information
From where data/document is obtainable
Rehabilitation school of Iran University of Medical sciences, Ali Khaghani
What processes are involved for a request to access data/document
After printing the article
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