Protocol summary

Study aim
To evaluate the effect of adding a local vibration system to an orthosis with approved efficacy, on thoracic kyphosis angle, back extensor muscle strength, pain, walking speed and Physical function in hyperkyphotic older adults.
Design
The parallel group randomized controlled clinical trial with blinded group recruitment.
Settings and conduct
Assessments, interventions, and data collection will be performed at university of social welfare and rehabilitation sciences. in the present study thoracic kyphosis angle as the primary outcome and back extensor muscle strength, pain, walking speed, Physical function, Health condition and orthosis comfort as the secoundry outcome will be measure.
Participants/Inclusion and exclusion criteria
Age more than 59 years. kyphosis angle of more than 50 degrees and less than 80 degrees Body mass index between 25 and 33 ability to independent walking without any assistive devices ability to wear orthosis independently for patients who aren't in the acute phase of osteoporosis and had no new osteoporotic vertebral fractures in recent 6 months. patients that don't use muscle recovery drugs. patients that had not had any spinal surgery before. patients that their Hyperkyphosis isn't due to trauma or other diseases like metastasis, Scheuerman kyphosis, scoliosis or any other inborn spinal malalignments like hemivertebra. Patients with no severe spinal pathologies like infection, tumour, spondylolysis, spondylolisthesis or any spinal degenerative disease like osteoarthritis. patients that had no severe or referral pain related to the spine or spinal stenosis, unstable cardiovascular, mental or neurologic disease or use of a pacemaker.
Intervention groups
The intervention group wears orthosis with a local vibration system and the control group wears orthosis without a local vibration system.
Main outcome variables
correction of spinal alighnment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190811044505N2
Registration date: 2023-02-14, 1401/11/25
Registration timing: prospective

Last update: 2023-02-14, 1401/11/25
Update count: 0
Registration date
2023-02-14, 1401/11/25
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
2023-05-22, 1402/03/01
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and fabrication of an intelligent local vibration system and A comparison between the effect of conventional TLO and TLO fitted with local vibration therapy system on Kyphosis angle, isometric strength of back extensor muscles and pain in Hyperkyphotic elderly.
Public title
Comparison of the effect of orthosis with or without local vibration system on thoracic kyphosis angle, back extensor muscle strength, pain and walking ability in hyperkyphotic older adults.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 59 years. kyphosis angle more than 50 degree and less than 80 degree Body mass index between 25 and 33 ability of independent walking without any assistive devices ability of wearing orthosis independently patients that they aren't in acute phase of osteoporosis and had not new osteoporotic vertebral fractures in recent 6 months.
Exclusion criteria:
Muscle recovery drugs use. Having any previous spinal surgery . Patients that their Hyperkyphosis is due to trauma or other disease like metastasis, Scheuerman kyphosis, scoliosis or any other inborn spinal malalignments like hemivertebra. Patients that had spinal severe pathologies like infection, tumor, spondylolysis, spondylolisthesis or any spinal degenerative disease like osteoarthritis. Patients that had severe or referral pain related to spine or spinal stenosis. Patients that had unstable cardiovascular, mental or neurologic disease or use of pace maker.
Age
From 59 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 18
Randomization (investigator's opinion)
Randomized
Randomization description
We used the block randomization method by the blockrand function in R4.2.2 software for the randomisation process. Finally, the arrangement of sample allocation attained.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study was conducted as single blind. In this study, only participants are blind to study groups. All participants received orthosis and they don't know were allocated to which group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of University of Social Welfare and Rehabilitation sciences
Street address
kodakyar Ave., daneshjo Blvd.,Evin, ، Tehran.
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2023-01-23, 1401/11/03
Ethics committee reference number
IR.USWR.REC.1401.217

Health conditions studied

1

Description of health condition studied
Hyperkyphosis
ICD-10 code
M40.14
ICD-10 code description
Other secondary kyphosis, thoracic region

Primary outcomes

1

Description
Thoracic kyphosis angle
Timepoint
Thoracic kyphosis angle measure before intervention and 21 and 42 days after orthosis use.
Method of measurement
Photogrammetry

Secondary outcomes

1

Description
Back extensor muscles strength
Timepoint
Back extensor muscle strength measure before intervention and 21 and 42 days after orthosis use.
Method of measurement
Force gauge

2

Description
Pain
Timepoint
Pain measure before intervention and 21 and 42 days after orthosis use.
Method of measurement
Visual analog scale

3

Description
Walking speed
Timepoint
Walking speed measure before intervention and 21 and 42 days after orthosis use.
Method of measurement
10 meter walk test, 2 minute walk test.

4

Description
Physical function
Timepoint
Physical function measure before intervention and 21 and 42 days after orthosis use.
Method of measurement
Timed up and go test

5

Description
Health condition
Timepoint
Health condition will measure before intervention.
Method of measurement
SF-36 Health survey questionnaire

6

Description
Orthosis comfort
Timepoint
Orthosis comfort measure before intervention and 42 days after orthosis use.
Method of measurement
Orthosis comfort personalized questionnaire

Intervention groups

1

Description
Intervention group: intervention group receives Spinal orthosis with imbedded local vibration system. this orthosis mechanically equal with control group orthosis but local vibration system works as local vibration therapy. frequency and displacement of local vibration system is based on muscle strength improvement protocol.
Category
Treatment - Devices

2

Description
Control group: Spinal orthosis without local vibration system
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Public announcement and adds
Full name of responsible person
Fatemeh Keshavarzi
Street address
kodakyar Ave., daneshjo Blvd.,Evin,Post, Tehran.
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
keshavarzifatemeh999@gmail.com

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
Kodakyar Ave., Daneshjo Blvd.,Evin, Tehran.
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
ha.khankeh@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
Fatemeh Keshavarzi
Position
Student
Latest degree
Master
Other areas of specialty/work
Orthotics and Prosthetics
Street address
kodakyar Ave., daneshjo Blvd.,Evin, Tehran.
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
keshavarzifatemeh999@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mokhtar Arazpour
Position
Professer
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and Prosthetics
Street address
kodakyar Ave., daneshjo Blvd.,Evin,Tehran.
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
009822180083
Email
M.arazpour@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Fatemeh Keshavarzi
Position
Student
Latest degree
Master
Other areas of specialty/work
Orthotics and Prosthetics
Street address
kodakyar Ave., daneshjo Blvd.,Evin, Tehran.
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
Keshavarzifatemeh999@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
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 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
Six weeks after request data will be sent.
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