the aim of this study is to investigate effect of sub thereshold vibration on balance control of elderly and subjects with reduced foot sensation
Design
this study is a clinical trial with cross over and double blinded design,
Settings and conduct
the place of performing this study is Djavad Mowafaghian Research Center, Sharif university. All participants are blind to balance condition tests. The investigator and the outcome assessor are also blind and the order of the tests is determined by the computer program. On the other hand, data is coded and another person analyze data who will not be aware of coding .
Participants/Inclusion and exclusion criteria
participant inclusion criteria including: older subject of above 60 years that have history of one falling in 6 month ago or subjects that postural instability was probed by disability in doing single leg stance correctly for 5 second or more. Also, subjects must walk at least 10 meter without any assistive. subjects must score 7 or above from AMT(Abbreviated Mental Test) and score up 2 from clock drawing test. if subjects have heart and pulmonary disease will exclude from study. Any history of lower limb surgery or orthopedic disease , having visual or vestibule deficit and also using some drugs that may interfere balance are considered exclusion criteria. if subject have body mass index 30 or above will not include in this study.
Intervention groups
intervention is orthopedic shoe when vibration is on
and second group is orthopedic shoe without vibration mechanism, after that with cross over design, the first group will receive orthopedic shoe and second group will receive orthopedic shoe with vibration on.
Main outcome variables
main outcome variable are: postural stability variable including center of pressure magnitude, velocity and phase plane portrait
secondary outcomes: Timed Up and Go (TUG) and Berg Balance Test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170422033568N1
Registration date:2018-04-30, 1397/02/10
Registration timing:registered_while_recruiting
Last update:2018-04-30, 1397/02/10
Update count:0
Registration date
2018-04-30, 1397/02/10
Registrant information
Name
atefeh aboutorabi
Name of organization / entity
university of social welfare and rehabilitation sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 153 3597
Email address
at.aboutorabi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of sub-sensory vibration on balance control in elderly subjects
Public title
effect of vibration on balance of elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
elderly above 60 years
history of one falling in 6 month ago or disability in doing single leg stance test for 5 second
Can walk about 10 m without no assistive
AMT (Abbreviated Mental Test) score 7 & above
score up to 2 for Clock Drawing test
Exclusion criteria:
having Heart and pulmonary diseases
Peripheral neuropathy or Diabetic
Visual & vestibular deficiency
BMI 30 and above
lower Limb surgery, Contraction, amputation
Alzimer
Dizziness
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
12
Actual sample size reached:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
1- all participant were blinded to performing postural stability tests (because of applying sub sensory vibration, participants were not aware in conditions vibration on or off)
2- investigator was blind to test conditions ( order of different condition was completely random and determined by computer software, so outcome assessor was blinded to test and vibration on/off
3- data was coded for every condition and subjects. so another person analyzed data.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
the primary outcome is balance that is measured via center of pressure displacement and velocity via force plate
Timepoint
outcome is measured immediately after intervention
Method of measurement
the primary outcome "center of pressure variable" is measured by force plate in biomechanic lab and secondary outcomes including Timed Up and Go and Berg Balance Test was recorded by therapist
Secondary outcomes
1
Description
secondary outcomes are Timed Up and GO test (TUG) and Berg Balance Test
Timepoint
these secondary outcome record 3 times after intervention immediately
Method of measurement
secondary outcomes records by checklist of TUG and Berg Balance Test by therapist
Intervention groups
1
Description
the first Intervention group: orthopedic shoe with vibration mechanism
Category
Treatment - Devices
2
Description
Second intervention: orthopedic shoe/ or orthopedic shoe without vibration mechanism
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Djavad Mowafaghian Research Center, Sharif University of Technology
Full name of responsible person
Atefeh Aboutorabi
Street address
No.11, Khark Street, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1133913813
Phone
+98 21 6671 6100
Fax
+98 21 6671 6101
Email
aboutorabito11@yahoo.com
Web page address
http://dmrcint.sharif.ir/web/dmrcinten
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Amir Massoud Arab
Street address
University of Social Welfare and Rehabilitation Sciences, kodakyar Ave., daneshjo Blvd.,Evin