The purpose of this study is a comparison on the effects of spinomed orthosis and posture-training support on risk of falling in elderly patients with spinal hyperkyphosis.The study includes local women and men who are older than 60 yr. The other inclusion criteria are the presence of thoracic kyphosis, measured on standing lateral radiograghy of the spine, showed a cobb angle ≥ 50. Subjects are not included in the study if they have a history of any progressive neurogenic or myopathic disorder that is known to impair motor function or if they are receiving drugs known or presumed affect the central nervous system or equilibrium. The duration of wearing of orthosis in each groups is considered for one and half in order to adapt with orthosis. The sample size is approximately 28 persons according to the formula.
Then they are randomly allocated into one of the three groups( spinomed, posture training support or control). Patients were randomly subjected to computerized dynamic posturography, which contained sensory organization tests(SOT) and limits of stability(LOS). The tests for each person was conducted in two conditions: while wearing and not wearing the orthosis, and the order of testing within a patient was randomized. The indices of LOS test are reaction time and directional control. The indice of SOT includes the composite balance score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101065520N3
Registration date:2011-01-28, 1389/11/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-28, 1389/11/08
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@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2010-01-21, 1388/11/01
Expected recruitment end date
2010-09-21, 1389/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison on the effets of spinomed orthosis and posture – training support on risk of falling in elderly patients with spinal hyperkyphosis
Public title
A comparison on the effets of two type spinal orthosis on balance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- they older than 60 yr.
2- cobb angle≥ 50.
Exclusion criteria:
1- they are receiving drugs known or presumed to affect the central nervouss system or equilibriums.
2- they have a history of any progressive neurogenic or myopathic disorder
3- having confirmed scoliosis with Adamz test
4- joint replacement in the lower extremitis
5- uncorrectable visual and vestibular deficitis
6- having the history of any fracture or operation in spine or lower exterimity
7- attending precedent in balance spinal exercises
8- the existence of low back or cervical pain on the test session which is rated by the patient more than 3 degree on visual analysis scale
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:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of rehabilitation, Tehran university of medical sciences
Street address
Faculty of rehabilitation, shahnazari street, Mader squ, Mirdamad blvd
City
Tehran
Postal code
Approval date
2010-01-13, 1388/10/23
Ethics committee reference number
221
Health conditions studied
1
Description of health condition studied
hyperkyphosis
ICD-10 code
R29.3
ICD-10 code description
Abnormal posture
Primary outcomes
1
Description
Balance score
Timepoint
before intervention and one and a half houre after intervention
Method of measurement
a score frome 0 to 100 by Equi Test System
2
Description
Directional control
Timepoint
before intervention and one and a half hour after intervention
Method of measurement
as a percentage by Balance Master System
3
Description
Reaction time
Timepoint
before intervention and one and a half after intervention
Method of measurement
as a percentage by Balance Master System
Secondary outcomes
empty
Intervention groups
1
Description
Spinomed orthosis ( intervention group )
Category
Other
2
Description
Posture Training Support ( intervention group )
Category
Other
3
Description
Placebo orthosis ( control group )
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Hamid Behtash private clinic
Full name of responsible person
Dr. Hamid Behtash
Street address
9 unite, 4th floor, 9 number, 8th Avenue. Miremad street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr. M.Moradi Lakeh
Street address
Vice-Chancellor for Research, Tehran 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
Vice-Chancellor for Research, Tehran 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
Rehabilitation School, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Kamyab
Position
PhD in Orthotics & Prosthetics, assistant professor of Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Department of orthotics & prosthetics, Faculty of Rehabilitation, Shahnazary street, Mader Square, Mirdamad Blvd