The present randomized controlled trial is mainly aimed to evaluate the effect of a posture supportive corset on thoracic kyphosis angle. Furthermore, the secondary aim is to evaluate the effect of this corset on back muscle performance and proprioception in elderly people with hyperkyphosis.
Design
The present study is a parallel group, randomized, controlled trial with blinded outcome assessors. Participants will be allocated to experimental or control groups through permuted block randomization.
Settings and conduct
Assessments, interventions, and data collection will be performed at School of Rehabilitation Sciences. In the present study, kyphosis angle will be considered the primary outcome and back muscle performance (strength and endurance) and proprioception (position sense and force sense) will be considered as secondary outcome measures.
Participants/Inclusion and exclusion criteria
Older adults that are in the sixth decade and more of their life that their BMI scale between 18 and 31 units and can walk without assistive devices and the independent wearing of the orthosis, will be invited. Pople with back pain in the past year, any surgery in the spine and limbs, any referral pain in the spine or limbs and those suffering from diabetics, or are in the acute phase of osteoporosis and detection of new compressive fracture of a vertebra in past 6 months, will not include.
Intervention groups
The experimental group wears posture supportive corset (orthosis) for 3 months, and the control group is advised to maintain their daily physical activity and will not receive any external support or exercise therapy.
Main outcome variables
Correction of spinal alignment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190811044505N1
Registration date:2020-04-06, 1399/01/18
Registration timing:prospective
Last update:2020-04-06, 1399/01/18
Update count:0
Registration date
2020-04-06, 1399/01/18
Registrant information
Name
Fatemeh Keshavarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2296 1901
Email address
keshavarzi.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2020-10-03, 1399/07/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of postural supportive corset on kyphosis angle and back extensor muscle performance in the elderly with hyperkyphosis
Public title
Measurement and treatment of thoracic kyphosis in elderly with hyperkyphotic posture
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 60 years old
BMI scale between 18 to 31
Ability of walking without help or assistive devices
Ability of wearing an orthosis independently
Exclusion criteria:
People with history of back pain in the last year.
people in the acute phase of osteoporosis and detection of new compressive fracture of a vertebra in the past 6 months.
History of fracture, surgery, or trauma in the spine and lower extremities
People with Hyperkyphosis in the result of trauma or metastasis, Hemivertebra, Scheuermann kyphosis, scoliosis or any congenital malformation.
People with any infection, spondylosis, spondylolisthesis or acute osteoarthritis in the spine.
People with any referral pain in spine or limbs.
Those suffering from diabetics and neurologic or psychological disorders.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessor and data analyzer will be blinded
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 Science
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-12-09, 1398/09/18
Ethics committee reference number
IR.IUMS.REC.1398.896
Health conditions studied
1
Description of health condition studied
Hyperkyphosis
ICD-10 code
M40.14
ICD-10 code description
Other secondary Hyperkyphosis, thoracic region
Primary outcomes
1
Description
Kyphosis angle
Timepoint
Before intervention, 6 weeks after intervention, 12 weeks after intervention
Method of measurement
Photogrammetry
Secondary outcomes
1
Description
Back extensor muscles endurance
Timepoint
Before intervention, 6 weeks after intervention, 12 weeks after intervention
Method of measurement
Force gauge, Timed loaded standing test, Ito test
2
Description
Back extensor muscles strength
Timepoint
Before intervention, 6 weeks after intervention, 12 weeks after intervention
Method of measurement
Force gauge
3
Description
Proprioception
Timepoint
Before intervention, 6 weeks after intervention, 12 weeks after intervention
Method of measurement
Position sense via photogrammetry and force sense via force gauge
Intervention groups
1
Description
Intervention group: posture supportive corset / orthosis, for the first two weeks, orthoses will be worn for 30 minutes a day. After that, orthosis will be worn for 2 hours a day for the next 4 weeks, and from sixth week will be worn 2 to 4 hours a day.
Category
Treatment - Devices
2
Description
Control group: no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Public announcement and adds
Full name of responsible person
Fatemeh Keshavarzi
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
keshavarzifatemeh999@gmail.com
Web page address
http://rehab.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sied Abas Motavalian
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Web page address
http://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
Fatemeh Keshavarzi
Position
Postgraduate Student in Prosthetics and Orthotics
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
keshavarzifatemeh999@gmail.com
Web page address
http://rehab.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Azadinia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
azadinia.f@iums.ac.ir
Web page address
http://rehab.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Keshavarzi
Position
Bachelor of science student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
002122961901
Email
keshavarzifatemeh999@gmail.com
Web page address
http://rehab.iums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data can be shared 1 year after article publication.
When the data will become available and for how long
Starting one year after article publication.
To whom data/document is available
Information is available to all researchers working in academic and scientific institutions.
Under which criteria data/document could be used
use of data is only possible by mentioning the name and organizational affiliation of the correspond and co-author of the project and the published article.
From where data/document is obtainable
Connect to Fatemeh Keshavarzi by email:
keshavarzifatemeh999@gmail.com
What processes are involved for a request to access data/document