design and construction of Postural Forward Head and Hyperkyphosis corrective Orthosis (FHKO) in youth people and evaluation of its 2-month effect with exercise training on craniovertberal angle of head and neck, thoracic kyphosis angle and electrical activity level of target muscles
• Design and construction of progressive postural corrective orthosis and thoracic hyperkyphosis in young people
• The effect of two-month orthosis with exercise training on the intensity of electrical activity of target muscles (anterior serratus, inferior trapezius, upper trapezius and sternocleoidomastoid) and protruding postural correction and thoracic hyperkyphosis
Design
In this study, firstly, orthosis modifying the forward head and thoracic hyperkyphosis (FHKO) for young people will be developed and then evaluated in a single-blind, randomized clinical trial (RCT) study, the effectiveness of orthosis with exercise training.
Non-probability sampling and available sampling will be done on 36 patients. .
Settings and conduct
To randomize the samples, random block method is used. For example, in the event of the ABBA sequence, the character A represents the assignment of the person to the exercise group, and character B represents the assignment of the person to the exercise group with orthotics Patients living in Arak city are evaluated in three stages, in the first then one month and then two months and variables are studied in them
Participants/Inclusion and exclusion criteria
inclusion criteria: 18 to 45 years old
The angle of kyphosis is greater than 42 degrees
Cranovertebral angle less than 48°
exclusion criteria: No Neuromuscular Diseases
Intervention groups
Subjects will be divided into two groups of control and test, the control group will receive corrective exercises and the test group will receive the designed orthosis along with corrective exercises.
Main outcome variables
Craniovertebral angle،
Thoracic kyphosis angle ،
Intensity of the electrical activity of the muscles.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231002059590N1
Registration date:2023-10-14, 1402/07/22
Registration timing:prospective
Last update:2023-10-14, 1402/07/22
Update count:0
Registration date
2023-10-14, 1402/07/22
Registrant information
Name
reza hamzelloui
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4633 9228
Email address
rezarh777@yahoo.com.sg
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
design and construction of Postural Forward Head and Hyperkyphosis corrective Orthosis (FHKO) in youth people and evaluation of its 2-month effect with exercise training on craniovertberal angle of head and neck, thoracic kyphosis angle and electrical activity level of target muscles
Public title
design and construction of Postural Forward Head and Hyperkyphosis corrective Orthosis (FHKO) in youth people and evaluation of its 2-month effect with exercise training on craniovertberal angle of head and neck, thoracic kyphosis angle and electrical activity level of target muscles
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 45 years Kyphosis angle greater than 42° Cranivertebral angle less than 48°
Exclusion criteria:
History of cervical vertebral surgery
A history of fracture, surgery or trauma in the spine and lower extremity within the past year according to the individual's report
Inflammatory diseases such as Ankylosing spondylitis and rheumatoid arthritis based on the individual's report
History of neurological diseases
Fracture in cervical vertebrae
Scoliosis above ten degrees.
Rheumatic diseases
Torticollis
Use of hearing aids.
Systemic diseases such as arthritis.
History of surgery or injury to the shoulder during the past year
BMI less than 18.5 and more than 25 kg/m2.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be non-probability and available sampling. To randomize the samples, random block method with R software is used. For example, in the sequence event of ABBA, the character A represents the assignment of the individual to the group of exercises, and character B represents the assignment of the individual to the group of exercises with orthotics.
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 University of Rehabilitation Sciences and Social Health
Street address
University of Rehabilitation Sciences and Social Health, Koodakyar St., Daneshjoo Blvd., Evin, Iran.
At the beginning of the study, one month and then two months after the start of the study
Method of measurement
Digital imaging to measure angles
2
Description
Thoracic kyphosis angle
Timepoint
At the beginning of the study, one month and then two months after the start of the study
Method of measurement
Digital imaging to measure angles
3
Description
Intensity of the electrical activity of the muscles
Timepoint
At the beginning of the study, one month and then two months after the start of the study
Method of measurement
electromyography to check the intensity of electrical activity
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group receive Designed kyphotic orthosis with corrective exercises for kyphosis and forward head posture (Three times a week) for two months.
Category
Rehabilitation
2
Description
The control group received only kyphotic postural correction exercises three times a week for two months.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rabiei Occupational Therapy Clinic
Full name of responsible person
reza hamzeloie
Street address
Arak Armaneh Street
City
arak
Province
Markazi
Postal code
3881917558
Phone
+98 86 4633 9228
Email
rezarh777@yahoo.com.sg
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
hamidreza khankeh
Street address
: University of Rehabilitation Sciences and Social Health, Koodakyar St., Daneshjoo Blvd., Evin, Iran
City
tehran
Province
Tehran
Postal code
3881917558
Phone
+98 86 4633 9228
Email
rezarh777@yahoo.com.sg
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
10
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
University of social welfare and rehabilitation sciences
Full name of responsible person
reza hamzeloei
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Orthopedics
Street address
Armenian Street
City
arak
Province
Markazi
Postal code
3881917558
Phone
+98 86 4633 9228
Email
rezarh777@yahoo.com.sg
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
reza hamzeloei
Position
student
Latest degree
Master
Other areas of specialty/work
Orthopedics
Street address
Armenian Street
City
arak
Province
Markazi
Postal code
3881917558
Phone
+98 86 4633 9228
Email
rezarh777@yahoo.com.sg
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
reza hamzeloei
Position
student
Latest degree
Master
Other areas of specialty/work
Orthopedics
Street address
Armenian Street
City
arak
Province
Markazi
Postal code
3881917558
Phone
+98 86 4633 9228
Email
rezarh777@yahoo.com.sg
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