Comparison of the effect of orthosis spinomed and Posture Training Support with exercise therapy on the ability to walk and energy consumption in the elderly with hyperkyphosis
Comparison of the effect of Spinomed orthosis and posture training support orthosis with exercise therapy on the ability to walk and energy consumption in the elderly with hyperkyphosis.
Design
Clinical trial with control group and two intervention groups, with parallel and randomized groups, is performed gradually on a simple type on 39 individuals.
Settings and conduct
Individuals are studied at the Center for the Elderly of the University of Social Welfare and Rehabilitation Sciences. In the first session, basic information (including: gender, height and weight of individuals) and tests related to the ability to walk and energy consumption will be recorded. Individuals in groups will be referred to the center again after 8 weeks of intervention and the tests will be repeated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 60-80 years, hyperkyphosis with an angle of 50 to 65 degrees, the ability to walk without aids
Exclusion criteria: any neuromuscular disease (neurological or myopathic), any sensory muscular dysfunction, joint replacement in the lower limb, history of fracture or surgery of the spine and lower limb in the last 12 months
Intervention groups
The control group received only exercise therapy, the first intervention group received spinal orthosis with exercise therapy and the second intervention group received PTS orthosis with exercise therapy.
Comparison of the effect of orthosis spinomed and Posture Training Support with exercise therapy on the ability to walk and energy consumption in the elderly with hyperkyphosis
Public title
The effect of spinal braces with exercise therapy in the elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People are 60-80 years old
People have a kyphosis angle of 50-65 degrees
People have the ability to walk without auxiliary devices
People are able to stand for at least two minutes without assistance
Individuals have the ability to score 1 or 2 on the clock drawing test
Exclusion criteria:
People who have any neurological or muscular diseases.
People with any sensory-muscular dysfunction.
People with scoliosis.
People who have had lower limb joint replacement.
People with hearing or vision impairment.
People with a history of spinal fractures or lower limb surgery in the past 12 months.
People who have back or neck pain at the time of evaluation with VAS more than 3.
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
39
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to one of three study groups with the help of a simple gradual random allocation method and receive the intervention of the same group. The randomization unit will be the client. With each patient's visit, one of the envelopes will be randomly selected by the patient and introduced as a study group. There will be no concealment in the study.
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 Social Welfare and Rehabilitation Sciences
Street address
Tehran University of Social Welfare and Rehabilitation Sciences, Evin, Daneshjoo Blvd., Koodkiar dead end
City
tehran
Province
Tehran
Postal code
1985713834
Approval date
2021-07-14, 1400/04/23
Ethics committee reference number
IR.USWR.REC.1400.109
Health conditions studied
1
Description of health condition studied
Hyperkyphosis
ICD-10 code
M40.13
ICD-10 code description
Other secondary kyphosis, cervicothoracic region
Primary outcomes
1
Description
Ability to walk (includes: distance traveled, walking speed and walking efficiency.)
Timepoint
First, the relevant tests are taken from the subjects in the first session before the intervention, and after 8 weeks of the intervention (which includes orthosis with exercise therapy or exercise therapy alone (control group)), individuals are asked to refer to the center again and the tests Will be taken.
Method of measurement
distance traveled (2- MWT) Two minutes of walking The maximum distance traveled is recorded (meters)/Walking speed (10-MWT) 10 meters A person walks. Time will be recorded in this distance. (M / s)/Walking efficiency (EMS) includes 7 functional dimensions that are examined in the person and will be given a score of 20 (score).
2
Description
Energy consumption
Timepoint
Energy consumption of individuals is recorded in the first session before the intervention and after 8 weeks of intervention (orthosis with exercise therapy or exercise therapy alone (control group)) people are asked to refer to the center and record energy consumption.
Method of measurement
Using the polar electro device, the heart rate at rest and activity is recorded and the amount of energy consumption is calculated in the physiological cost index formula.
3
Description
Thoracic kyphosis angle
Timepoint
The Thoracic kyphosis angle will be recorded in the first session before the intervention. After 8 weeks of intervention (orthosis with therapeutic exercise or exercise therapy alone (control group)) again, individuals are asked to refer to the center and record the angle.
Method of measurement
It will be recorded using a kyphometer device.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Posture Training Suport orthosis with exercise therapy ,It is a small orthosis that prevents excessive bending by torque backwards on the spine. The orthosis is prefabricated, consisting of a sac located at the back just below the lower angle of the scapula and measuring 10-20 cm long and 5-10 cm wide. The orthosis will be ordered from Technotan Company in small, medium, large and very large sizes depending on the patient's size and will be covered by the orthotist on the patient's body. The person is asked to wear it for at least 2 hours a day during daily activities. Exercise therapy (exercise therapy) includes exercises (8 exercises) to strengthen the back muscles. These exercises repeat the contraction of the muscles of the dorsal extensor muscles 10 times, reducing the angle of thoracic kyphosis without increasing lumbar lordosis. The person is asked to perform these exercises in home every day as instructed and will be re-evaluated after 8 weeks.
Category
Rehabilitation
2
Description
Intervention group: Spinomed orthosis with exercise therapy, The orthosis is small , creating a backward torque to counteract excessive forward bending. It is a prefabricated orthosis that extends vertically up to the shoulder (1-5 cm below C7) from an abdominal pad, a vertical metal pad on the back, a belt and shoulder straps. The orthosis will be ordered from Technotan Company in small, medium, large and very large sizes depending on the patient's size and will be covered by the orthosis specialist based on the patient's size. The person is required to use at least two hours a day during daily activities. Exercise therapy (exercise therapy) includes exercises (8 exercises) to strengthen the back muscles. These exercises repeat the contraction of the back extensor muscles 10 times, reducing the angle of thoracic kyphosis without increasing lumbar lordosis. The person is asked to do these exercises in home every day as instructed and will be re-evaluated after 8 weeks.
Category
Rehabilitation
3
Description
Control group: exercise therapy, includes exercises (8 exercises) to strengthen the back muscles. These exercises repeat the contraction of the back extensor muscles 10 times, reducing the angle of thoracic kyphosis without increasing lumbar lordosis. The person is asked to do these exercises in home every day as instructed and will be re-evaluated after 8 weeks
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Elderly Center of Tehran University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
zahra mirzaye
Street address
Evin, Daneshjoo Blvd., Koodkiar St., Tehran University of Social Welfare and Rehabilitation Sciences, Aging Research Center
City
tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0154
Email
IRCA@USWR.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. Hamidreza Khorram Khorshid
Street address
Evin, Daneshjoo Blvd., Koodkiar St., University of Social Welfare and Rehabilitation Sciences, Farabi Building, Second Floor
City
tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2832
Email
rd@uswr.ac.ir
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
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
University of social welfare and rehabilitation sciences
Full name of responsible person
hanie khojasteh
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Orthosis_Prothesis
Street address
Evin, Daneshjoo Blvd., Koodkiar St., University of Social Welfare and Rehabilitation Sciences
City
tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0109
Email
hani_khojasteh@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
hanie khojasteh
Position
masters student
Latest degree
Bachelor
Other areas of specialty/work
Orthosis_Prothesis
Street address
Evin, Daneshjoo Blvd., Koodkiar St., University of Social Welfare and Rehabilitation Sciences
City
tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0109
Email
hani_khojasteh@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
hanie khojasteh
Position
masters student
Latest degree
Bachelor
Other areas of specialty/work
Orthosis_Prothesis
Street address
Evin, Daneshjoo Blvd., Koodkiar St., University of Social Welfare and Rehabilitation Sciences
City
tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0109
Email
hani_khojasteh@ymail.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
It is not possible to share all the data and only the demographic information of the participants and the results of the study evaluation variables are shared.
When the data will become available and for how long
Start of data access period 6 months after the publication of the article
To whom data/document is available
Researchers working in academic centers who intend to use these findings in systematic review and meta-analysis
Under which criteria data/document could be used
Other researchers as well as therapists in the field of medicine and rehabilitation can use this study after the publication of the article.
From where data/document is obtainable
University of Social Welfare and Rehabilitation Sciences, Hanie Khojasteh(hani_khojasteh@ymail.com)
What processes are involved for a request to access data/document
After requesting the documents, it is necessary for the person in charge of the research project to receive a written permit from the university and send the documents after obtaining the permit. Therefore, it is estimated that about 6 months after the request, this data will be sent.