The Effect of Whole Body Vibration on Balance and fear of falling in the elderly
Design
A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 40 patients, will enrolled between March 2020 and September 2020.
Settings and conduct
This study will be carried out at the Neuromuscular Rehabilitation Center of Semnan University of Medical Sciences. After allocation, two groups were randomly assigned into intervention and control groups, a blinded assessor, will evaluate the balance in elderly.Then, an experienced therapist, intervened the participants via the whole body vibration for the intervention group for 12 sessions. After the intervention, the static and dynamic balance of the participants will be evaluated by the blinded evaluator of the target group.
Participants/Inclusion and exclusion criteria
1- Men and women over 60 years old
2- Able to walk without the help of others and not to use crutches and other aids
Intervention groups
In this study, the elderly aged 60 years and older will assigned into two intervention and control groups.
Main outcome variables
Static and dynamic balance indices including overall, anterior-posterior and medial-lateral.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200203046353N1
Registration date:2020-02-16, 1398/11/27
Registration timing:prospective
Last update:2020-02-16, 1398/11/27
Update count:0
Registration date
2020-02-16, 1398/11/27
Registrant information
Name
Aliakbar Pahlevanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
alipahlevanian@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-05, 1398/12/15
Expected recruitment end date
2020-09-15, 1399/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Whole Body Vibration on Balance and fear of falling in the elderly
Public title
The Effect of Whole Body Vibration on Balance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women over 60 years old
Able to walk without the help of others and not to use crutches and other aids
Exclusion criteria:
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were randomly assigned into intervention and control groups according to the inclusion criteria. Subjects will be randomly assigned to either intervention or control groups following the simple randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
1. The person who evaluates the results of the study will also blind the allocation of the groups. 2. An individual analyzing the results will also blind the allocation of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Basij Blvd,
City
Semnan
Province
Semnan
Postal code
۹۹۹۵۱- ۳۵۱۹۸
Approval date
2019-12-17, 1398/09/26
Ethics committee reference number
IR.SEMUMS.REC.1398.210
Health conditions studied
1
Description of health condition studied
Elderly
ICD-10 code
Z76.8
ICD-10 code description
Persons encountering health services in other specified circumstances
Primary outcomes
1
Description
overall, anterior- posterior and medial-lateral of balance
Timepoint
Measurement of the balance before and immediately after 12 sessions of whole body vibration
Method of measurement
BIODEX instrument
Secondary outcomes
1
Description
Fear Of Falling
Timepoint
Before and after intervention
Method of measurement
Fall Efficacy Scale(FES)
Intervention groups
1
Description
Intervention group:Whole body vibration for 12 sessions, 3 sessions per week at 35 Hz, 10 repetitions with 60 seconds, 60 seconds rest between each repetition.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn-e-Sina Rehabilitation Clinic
Full name of responsible person
aliakbar pahlevanian
Street address
Next to Sepah Bank., 17 shahrivar Blvd., Semnan town
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
alipahlevanian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Parviz Kokhaei, Research & Technology Deputy of University
Street address
Basij Blvd., Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
99951- 35198
Phone
+98 23 3334 1022
Email
alipahlevanian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
aliakbar pahlevanian
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Basij Blvd.,Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
99951- 35198
Phone
+98 23 3334 1022
Email
alipahlevanian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
aliakbar pahlevanian
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Basij Blvd.,Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
سمنان، بلوار بسیج
Phone
+98 23 3334 1022
Email
alipahlevanian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
aliakbar pahlevanian
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Basij Blvd.,Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
99951- 35198
Phone
+98 23 3334 1022
Email
alipahlevanian@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available