Protocol summary

Study aim
Evaluation of the effect of orthosis and taping not only in correction of thoracic spine alignment but also pelvic and cervical alignment and also its effect on postural control strategies
Design
Randomized clinical trial, with parallel groups and single-blind on 48 patients. Randomizer site will be used for randomization.
Settings and conduct
The study will be conducted in the Faculty of Rehabilitation of Iran University of Medical Sciences. Spinal and pelvis sagittal alignment will be examined by radiography and postural control by a force plate, and the data analyzer will be blind to type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age more than 60 years, kyphosis angle more than 50 degree, capability of walking without assistive devices Exclusion criteria: history of fracture or trauma to the spine and lower extremities, history of spinal surgery, history of inflammatory diseases such as ankylosing spondylosis, rheumatoid arthritis, history of central nervous system diseases, neuromuscular disorders and diabetes neuropathy, bone density with a T-score less than -1, history of vestibular disease and dizziness, history of cardiovascular diseases, history of diseases of the lymphatic and kidney system, visual and auditory disorders that can not be corrected, history of falls more than twice in the last six months, history of knee osteoarthritis, cognitive impairment with AMTS≤6 score, use of drugs affecting the central nervous system or balance, inability to wear orthoses, sensitivity to taping
Intervention groups
In group one, orthosis will be worn for 13 weeks for two hours a day, in group two for 13 weeks, postural tape will be received. There will be 2 taping programs per week for up to 13 weeks.
Main outcome variables
Spinal and pelvis sagittal alignment; Nonlinear and linear analysis of postural control, balance performance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170803035480N2
Registration date: 2022-06-21, 1401/03/31
Registration timing: prospective

Last update: 2022-06-21, 1401/03/31
Update count: 0
Registration date
2022-06-21, 1401/03/31
Registrant information
Name
Mostafa Hosseinabadi
Name of organization / entity
School of Rehabilitation Sciences, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
hosseinabadi.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-06, 1401/05/15
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of hyperkyphosis orthosis and postural kinesiotaping on spino-pelvic sagittal alignment and postural control strategy of the elderly with hyperkyphosis
Public title
Comparison of the effect of orthosis and kinesiotaping on posture and balance of the elderly with hyperkyphosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age≥60 years Kyphosis angle ≥ 50 Capability of walking without assistive devices
Exclusion criteria:
History of cervical, spinal or lower limb fracture and/or trauma, severe spinal pathologies and deformities, cervical and spinal surgery History of inflammatory diseases such as ankylosing spondylitis, and rheumatoid arthritis History of disease of the central nervous system, neuromuscular disorder, and diabetic neuropathy Bone mineral density with T-Score less than -1 History of vestibular disease, and dizziness Foot deformities History of cardiovascular disease History of diseases of the lymphatic and kidneys system Uncorrectable visual or vestibular impairments History of joint replacement in the lower limb History of falls more than twice in the last six months History of grade 2 and 3 osteoarthritis of the knee based on the Kellgren-Lawrence scale in one or both legs Cognitive impairment with AMTS≤6 score Taking drugs known to affect the central nervous system or equilibrium inability to put on orthosis taping Sensitivity
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
In order to divide participations into two intervention groups, will be prepared lists of random numbers and patients will be assigned to two groups based on random blocking that will be made by the software. In order to conceal the allocation, the codes determining the type of intervention will be kept in sealed envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer is kept blind to the type of intervention
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-05-31, 1401/03/10
Ethics committee reference number
IR.IUMS.REC.1401.180

Health conditions studied

1

Description of health condition studied
Thoracic kyphosis
ICD-10 code
M40.1
ICD-10 code description
Other secondary kyphosis

Primary outcomes

1

Description
Thoracic Kyphosis
Timepoint
Before intervention, 3 months after intervention
Method of measurement
EOS radiography

Secondary outcomes

1

Description
Lumbar lordosis
Timepoint
Before intervention and 3 months after intervention
Method of measurement
EOS radiography

2

Description
Pelvic Incidence
Timepoint
Before intervention and 3 months after intervention
Method of measurement
EOS radiography

3

Description
Pelvic Tilt
Timepoint
Before intervention and 3 months after intervention
Method of measurement
EOS radiography

4

Description
Sacral Slope
Timepoint
Before intervention and 3 months after intervention
Method of measurement
EOS radiography

5

Description
Sagittal Vertical Axis
Timepoint
Before intervention and 3 months after intervention
Method of measurement
EOS radiography

6

Description
Cervical Sagittal Vertical Axis
Timepoint
Before intervention and 3 months after intervention
Method of measurement
EOS radiography

7

Description
T1 Slope
Timepoint
Before intervention and 3 months after intervention
Method of measurement
EOS radiography

8

Description
Cervical Lordosis
Timepoint
Before intervention and 3 months after intervention
Method of measurement
EOS radiography

9

Description
Open loop control
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Force plate

10

Description
close loop control
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Force plate

11

Description
Critical displacement
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Force plate

12

Description
Critical time
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Force plate

13

Description
Anteroposterior mean velocity
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Force plate

14

Description
Radial mean velocity
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Force plate

15

Description
Sway area per unit time
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Force plate

16

Description
Balance performance
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Mini balance evaluation systems test

Intervention groups

1

Description
Intervention group: orthosis
Category
Rehabilitation

2

Description
Intervention group: kinesiotaping
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation school of Iran university of medical sciences
Full name of responsible person
Behnam Hajiaghaei
Street address
School of Rehabilitation Sciences, Madadkaran Alley, Shah'nazari St. Madar Sq. Mirdamad Blv.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
Mostafahosseinabadi.mn@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Keyvani
Street address
Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
info@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
Maryam Jalali
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and Prothtetics
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Fax
Email
Jalali.m@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Jalali
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and Prothtetics
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Fax
Email
Jalali.m@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mostafa Hosseinabadi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Orthotics and prosthetics
Street address
Department of Orthosis & prosthesis, School of rehabilitation Sciences, Shahnazari St, Madar Sq, Mir
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Fax
Email
hosseinabadi.m@tak.iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after encoding and being unrecognizable
When the data will become available and for how long
6 months after publish
To whom data/document is available
Only for researchers in academic and scientific institutions
Under which criteria data/document could be used
For use in systematic review and meta-analysis articles
From where data/document is obtainable
Corresponds author
What processes are involved for a request to access data/document
After email to the corresponds author and with the approval of co-author
Comments
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