To investigate the immediate effects of thoracolumbar back brace, plastic body jacket, and trunk corset on the balance of older people with osteoprotic hyperkyphosis
Design
A crossover study with a group of 20 participants who act as their own controls and receive one of three interventions and a control condition.
Settings and conduct
There is a convenience sampling method. participants will be recruited from the outpatient clinic of Alzahra hospital, Isfahan, Iran. The outcomes will be measured immediately after wearing each orthosis (intervention) and control condition (no orthosis).
Participants/Inclusion and exclusion criteria
Having an osteoprotic hyperkyphosis, age over 60 years, the history of two sudden falls in the last recent year, and cognitive ability to give informed consent
Intervention groups
The study interventions include:
Intervention one: Spinomed orthosis
Intervention two: plastic body jacket
Intervention three: thoracplumbar flexible corset
Control condition: no orthosis
Main outcome variables
Postural stability, balance and gait of participants are assessed.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150210021034N7
Registration date:2020-03-27, 1399/01/08
Registration timing:retrospective
Last update:2020-03-27, 1399/01/08
Update count:0
Registration date
2020-03-27, 1399/01/08
Registrant information
Name
Ebrahim Sadeghi-Demneh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5235
Email address
sadeghi@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
2017-12-31, 1396/10/10
Actual recruitment end date
2018-09-11, 1397/06/20
Trial completion date
2018-09-21, 1397/06/30
Scientific title
The immediate effects of thoracolumbar back brace, plastic body jacket, and trunk corset on the balance of older people with osteoprotic hyperkyphosis
Public title
Orthotics in osteoprotic hyperkyphosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having an osteoprotic hyperkyphosis
Age over 60 years
The history of two sudden falls in the last recent year
Cognitive ability to give informed consent
Exclusion criteria:
Severe visual or vestibular dysfunction
History of fracture or surgery in the spine
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethical committee of Isfahan University of Medical Sciences, Isfahan, Iran
Street address
Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-10-29, 1396/08/07
Ethics committee reference number
IR.MUI.REC.1396.3.523
Health conditions studied
1
Description of health condition studied
Osteoporotic hyperkyphosis
ICD-10 code
M40.15
ICD-10 code description
Other secondary kyphosis, thoracolumbar region
Primary outcomes
1
Description
Postural stability
Timepoint
Before intervention and right away after receiving intervention
Method of measurement
Participants are asked to stand quiet on the force-plate while put the feet together and keep the arms relaxed beside the body. The center of pressure is recorded during 60 second of standing.
2
Description
Timed get up and go
Timepoint
Before intervention and right away after receiving intervention
Method of measurement
Participants sit on a chair to start the test They are asked to walk with maximum speed during test. They rise with a "go" signal and walk until reach a line at 3 meters distance from the chair then turn and walk back to the chair and sit on it. The time is recorded using a stopwatch.
3
Description
Forward reach distance
Timepoint
Before intervention and right away after receiving intervention
Method of measurement
Participants stand with feet together and raise the arm at their shoulder level then leaning forward as much as could with heels in contact with the ground. The anterior displacement of the hand is measured using a yardstick or tape.
Secondary outcomes
empty
Intervention groups
1
Description
Spinomed-designed orthosis; This orthosis includes a semi-rigid structure on the back and shoulder straps which fit the orthosis on the body. The back structure is formed on the spinal curve.
Category
Treatment - Devices
2
Description
Flexible thoracolumbar corset; This flexible corset has two posterior uprights to support the spine and anterior straps that fit the corset on the body.
Category
Treatment - Devices
3
Description
Plastic body jacket; This is a rigid bi-valved orthosis that fits on the body and supports the spine.