The comparison of Spinomed and Elderly Spinal Orthosis on Kyphosis Angle, Back Pain and Quality of Life in Elderly with Thoracic Hyperkyphosis.
Design
A randomized controlled clinical trial with parallel groups, single blind, randomized, Sample size is 60 elderly people over 60 years old.
Settings and conduct
The study population is among the elderly referred to Rasoul Akram Medical Center. Using envelopes the randomization process of the study variables is performed and for blinding, individuals from different groups will be referred on different days.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Kyphosis angle above 50 degrees; Ability to sit and stand up and walk at least 10 meters independently; 60 years or older.
Exclusion criteria:
Physical abnormalities that are more important than kyphosis or impair the research process; People who had a history of fracture or surgery in the lower extremity or spine 12 months before the start of the study; Any illness or disorder that disables one's participation in sports and group activities.
Intervention groups
Intervention group 1:The first group received both Spinomed Orthosis and Back School exercise.
Intervention group 2:The second group received simultaneous spinal orthosis of aging and back school exercise.The people of each group come to Hazrat Rasoul Hospital on a specific day of the week until the end of treatment and under the supervision of a sports medicine specialist they perform their group exercises and their orthoses are adjusted by the relevant expert. Everyone is given their own workout schedule to continue their workouts at home during the week. The duration of wearing the orthosis is 2 hours a day.
control group: control group, will only do the back school exercise.Duration of exercise and method of exercise is similar to intervention group.
Main outcome variables
Angle of kyphosis; Quality of Life; pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140811018762N2
Registration date:2020-02-22, 1398/12/03
Registration timing:registered_while_recruiting
Last update:2020-02-22, 1398/12/03
Update count:0
Registration date
2020-02-22, 1398/12/03
Registrant information
Name
Mojtaba Kamyab
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0947
Email address
kamyab.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Spinomed and Elderly Spinal Orthosis on Kyphosis Angle, Back Pain and Quality of Life in Elderly with Thoracic Hyperkyphosis.
Public title
The comparison of Spinomed and Elderly Spinal Orthosis on Kyphosis Angle.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Kyphosis angle above 50 degrees.
Ability to sit and stand up and walk at least 10 meters independently.
60 years or older.
Exclusion criteria:
Physical abnormalities that are more important than kyphosis or impair the research process.
People who had a history of fracture or surgery in the lower extremity or spine 12 months before the start of the study.
Any illness or disorder that disables one's participation in sports and group activities.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After the first visit to the clinic, individuals choose their treatment envelope from the available envelopes for each treatment group without knowing the groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
After the first visit to the clinic, individuals choose their treatment envelope from the available envelopes for each treatment group without knowing the groups. The groups receive their treatment separately.
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
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-08-31, 1398/06/09
Ethics committee reference number
IR.IUMS.REC.1398.494
Health conditions studied
1
Description of health condition studied
Thoracic hyperkyphosis
ICD-10 code
M40.04
ICD-10 code description
Postural kyphosis, thoracic region
Primary outcomes
1
Description
The kyphosis angle
Timepoint
At the beginning and end of the study (three months after the first evaluation).
Method of measurement
Inclinometer and radiograph
2
Description
Quality of Life
Timepoint
At the beginning and end of the study (three months after the first evaluation).
Method of measurement
SF36 questionnaire.
3
Description
Pain
Timepoint
At the beginning and end of the study (three months after the first evaluation).
Method of measurement
Visual Analogue Scale.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group received both Spinomed Orthosis and Back School exercise.The duration of use of orthosis and exercise is 3 months. The people of this group come to Hazrat Rasoul Hospital on a specific day of the week until the end of treatment and under the supervision of a sports medicine specialist they perform their group exercises and their orthoses are adjusted by the relevant expert. Everyone is given their own workout schedule to continue their workouts at home during the week. The duration of wearing the orthosis is 2 hours a day.
Category
Rehabilitation
2
Description
Intervention group: The second group received simultaneous elderly spinal orthosis and back school exercise.The duration of use of orthosis and exercise is 3 months. The people of this group come to Hazrat Rasoul Hospital on a specific day of the week until the end of treatment and under the supervision of a sports medicine specialist they perform their group exercises and their orthoses are adjusted by the relevant expert. Everyone is given their own workout schedule to continue their workouts at home during the week. The duration of wearing the orthosis is 2 hours a day.
Category
Rehabilitation
3
Description
Control group: The third group, which is the control group, will only do the back school exercise. Exercise time is 3 months. The control group is referred to Hazrat Rasoul Hospital on a specific day of the week until the end of treatment and under the supervision of a sports medicine specialist they perform group exercises.Everyone is given their own workout schedule to continue their workouts at home during the week.
School of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Mirdamad Square, Iran
City
Tehran
Province
Tehran
Postal code
1545913478
Phone
+98 21 2222 0947
Email
kamyab.m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Dr. Mojtaba Kamyab
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
School of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Mirdamad Square, Iran
City
Tehran
Province
Tehran
Postal code
1545913478
Phone
009822220947
Email
kamyab.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Kamyab
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
School of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Mirdamad Square, Iran
City
Tehran
Province
Tehran
Postal code
1545913478
Phone
009822220947
Email
kamyab.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Rahimi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No. 33, Gholami Street, Shahid Ghayebi Square, Rey
City
Tehran
Province
Tehran
Postal code
1841865597
Phone
+98 21 5593 3888
Email
zahra.rahimi670@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
Yes - There is 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
Yes - There is 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
The outcomes of this study will be interpreted into a manuscript and will be submitted to a peer reviewed journal
When the data will become available and for how long
Starting data access period 6 months after the article is published.
To whom data/document is available
Researchers working in academic centers who plan to use these findings in a systematic review and meta analysis.
Under which criteria data/document could be used
Due to the presence of the authors of this article in the academic center, there is a need for written permission from the university to submit data. Therefore, data will be sent no later than 6 months after applying for a written permission from the university.
From where data/document is obtainable
School of Rehabilitation Sciences, Iran University of Medical Sciences, Dr Kamyab, Zahra Rahimi
What processes are involved for a request to access data/document
Upon requesting the documentation, the researcher must obtain written approval from the university and submit the documentation after obtaining permission. Therefore,wiht a time estimate of about 6 months after the request will be sent.