Protocol summary

Summary
The first aim of this study is to investigate the effect of orthosis on proprioception, force sense, and muscle endurance. A second aims to verify whether decrease in thoracic curve will be associated with improvement in forward head posture, and in finally investigate the relationship between changes in thoracic proprioception, force sense, extensor muscle endurance, thoracic kyphosis and forward head posture with balance performance. This study is a parallel group randomized controlled trial. The sample size will be 44 subject. Older adults (age≥60 years) with thoracic kyphosis angle ≥ 50 and capability of walking without assistive devices will be eligible. Subjects with history of cervical, spinal or lower limb fracture and/or trauma, severe spinal pathologies and deformities, cervical and spinal surgery, disease of the central nervous system, neuromuscular disorder, and severe osteoporosis, will be excluded. Furthermore, using of drugs known to affect the central nervous system or equilibrium, and muscle strength will be led to exclusion. Subjects in the experimental group will receive Spinomed. Subject 13 weeks will be instructed to wear Spinomed for 2–4 h daily with keep daily physical activity in the orthosis group and keep daily physical activity in the control group. In this study we will measured thoracic kyphosis with inclinometer, proprioception and force sense with re-position error test, muscle endurance with Ito test, forward head posture with craniovertebral angle and balance with berg balance scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017080335480N1
Registration date: 2017-10-02, 1396/07/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-02, 1396/07/10
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
Iran University of Medical Sciences
Expected recruitment start date
2017-09-25, 1396/07/03
Expected recruitment end date
2018-01-04, 1396/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Spinomed Orthosis on Effective parameters in Elderly's Balance performance with Hyperkyphosis
Public title
spinal orthotic management of the elderly people with hyperkyphosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: age≥60 years kyphosis angle ≥ 50 capability of walking without assistive devices Exclusion: with history of cervical, spinal or lower limb fracture and/or trauma, severe spinal pathologies and deformities, cervical and spinal surgery, inflammatory diseases such as ankylosing spondylitis, rheumatoid arthritis, disease of the central nervous system, neuromuscular disorder, diabetic neuropathy, vestibular disease, dizziness, uncorrectable visual or vestibular impairments, Severe osteoporosis, foot deformities using of drugs known to affect the central nervous system or equilibrium (i.e., sedatives or anxiolytics), and of drugs known to affect muscle strength (i.e., corticosteroids), back or neck pain at the time of examination reported to be higher than 3 on the Visual Analogue Scale (VAS), and inability to put on Spinomed
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: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
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
Postal code
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.IUMS.REC 1396.9411502002

Health conditions studied

1

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

Primary outcomes

1

Description
Muscle Endurance
Timepoint
Before Intervention,5 weeks After Intervention,9 weeks After Intervention,13 weeks After intervention
Method of measurement
Ito Test and chronometer

2

Description
Forward Head Posture
Timepoint
Before Intervention,5 weeks After Intervention,9 weeks After Intervention,13 weeks After intervention
Method of measurement
Photographic and Craniovertebral Angle

3

Description
proprioception
Timepoint
Before Intervention,5 weeks After Intervention,9 weeks After Intervention,13 weeks After intervention
Method of measurement
Re-position Error Test and Inclinometer

4

Description
Force Sense
Timepoint
Before Intervention,5 weeks After Intervention,9 weeks After Intervention,13 weeks After intervention
Method of measurement
Re-position Error Test and Dynamometer

5

Description
Balance
Timepoint
Before Intervention,5 weeks After Intervention,9 weeks After Intervention,13 weeks After intervention
Method of measurement
Berg Balance Scale and Timed up and Go Test

6

Description
Kyphosis
Timepoint
Before Intervention,5 weeks After Intervention,9 weeks After Intervention,13 weeks After intervention
Method of measurement
Inclinometer

Secondary outcomes

empty

Intervention groups

1

Description
Spinomed Orthosis, 2 weeks 30 Minutes per Day, 3 Weeks 2 Hour per Day, and 8 Weeks 2-4 Hour per Day
Category
Treatment - Other

2

Description
No treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Nursing Homes
Full name of responsible person
Street address
City
Tehran

2

Recruitment center
Name of recruitment center
Day Care Centers
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Javad Moosavi
Street address
Hemmat Highway, Iran University of Medical Sciences
City
Tehran
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Mostafa Hosseinabadi
Position
Postgraduate Student in Prosthetics & Orthotics
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
Hosseinabadi.M@tak.iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Mojtaba Kamyab
Position
Ph.D in Prosthetics & Orthotics
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
Kamyab.m@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Rehabilitation, Iran University of Medical Sciences
Full name of responsible person
Mostafa Hosseinabadi
Position
Postgraduate Student in Prosthetics & Orthotics
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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