The aim of this study is to compare the effects of whole body vibration while wearing unstable shoes and standard shoes on balance of elderly over 65. Older people are included if they gain a score of 25-35 (out of 40) in Fullerton Advance Balance scale and can walk independently for a distance of 20 meters. Elderly people with severe diabetes, kidney stones or bladder disorder ; noticeable and unmodified audio or visual content and elderly who have received balance training in the last 3 months will not be studied. A convenience sample of 60 people over 65 years will be recruited from Jahandidegan Older Comminuty Center in Shiraz, Iran. The participants will be randomly divided into two groups of 30 people. The first group whole body vibration and simple shoes and the second group will receive whole body vibration and unstable shoes.The total study lasts 4 weeks. With a frequency of three times a week and each session is 5 sets. Intervention and rest time per set, respectively first and second in two weeks, 30 seconds -1 minute, and minutes will be 1 min -1. Four weeks after the end of treatment, we will follow up and re-examine the outcome meadures. Selected frequency and amplitude for system is 30 Hz and 4 mm . Outcome measures are : balance ability measured by Fullerton Advance Balance Scale, Gait Speed and fear of falling measured by Fall Efficacy Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111825105N1
Registration date:2016-03-04, 1394/12/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-04, 1394/12/14
Registrant information
Name
Sobhan Sobhani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71136271551
Email address
sobhanis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Scineces
Expected recruitment start date
2016-05-01, 1395/02/12
Expected recruitment end date
2016-10-01, 1395/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of whole body vibration alone and in combination with unstable shoes on the balance of healthy older adults
Public title
Comparison of the effects of whole body vibration alone and in combination with unstable shoes on the balance of healthy older adults
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: people older than 65 ؛ receiving the point between 25-35 from FAB scale ؛ ability of walking 20 meters independently ؛ receiving the point over 6 (from 15) in geriatric depression scale ؛ receiving the point lesser than 23(from 30) in mini mental state test ؛ able to maintain semi squat position for at least one minute
exclusion criteria : elderly has been suffering from severe DM , kidney and bladder stone ؛ significant and not treated visual and vestibular impairments ؛ sever musculoskeletal , cardiovascular and neurological disorders ؛ elderly were receiving balance training in past three months ؛ fracture ؛ osteoprosis ؛ severe osteoarthritis ؛ taking sedative drugs
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand avenue -shiraz
City
Shiraz
Postal code
1978-71345
Approval date
2016-01-24, 1394/11/04
Ethics committee reference number
IR.SUMS.REC.1394.192
Health conditions studied
1
Description of health condition studied
balance impairment
ICD-10 code
Not Specif
ICD-10 code description
Not Specified
Primary outcomes
1
Description
Fullerton Advance Balance scale(FAB)
Timepoint
Pre and post intervention
Method of measurement
Rating on balance scale
Secondary outcomes
1
Description
Gait Speed
Timepoint
Pre and post intervention
Method of measurement
10 meter walking test
2
Description
Added at 2016-11-19: Fear of Falling
Timepoint
Added at 2016-11-19: pre-post intervention
Method of measurement
Added at 2016-11-19: Fall Efficacy Scale
Intervention groups
1
Description
The intervention group will receive simultaneously the Whole Body Vibration and unstable shoes; Duration of intervention will be for 4 weeks with a frequency of three times per week. Each session contains 5 bouts of treatment (whole body vibration while wearing unstable shoes), with hold and rest periods. The hold-rest ratio will be 30-60 seconds, and 60-60 seconds in the first two weeks and second two weeks respectively. The frequency and amplitude of the applied whole body vibration will be 30 Hz and 3 mm .
Category
Treatment - Devices
2
Description
The control group will receive simultaneously the Whole Body Vibration and standard shoes, similar in color and brand to unstable shoes; Duration of intervention will be for 4 weeks with a frequency of three times per week. Each session contains 5 bouts of treatment (whole body vibration while wearing unstable shoes), with hold and rest periods. The hold-rest ratio will be 30-60 seconds, and 60-60 seconds in the first two weeks and second two weeks respectively. The frequency and amplitude of the applied whole body vibration will be 30 Hz and 3 mm.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Jahandidegan older community center
Full name of responsible person
Sobhan Sobhani
Street address
School of Rehabilitation Sciences , Abiverdi1 avenue , Chamran Blvd
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran Postal Code
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Science
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
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Full name of responsible person
Dr. Sobhan Sobhani
Position
Assistant Professor, PT, PhD
Other areas of specialty/work
Street address
School of Rehabilitation Sciences , Abiverdi1 avenue , Chamran Blvd
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
sobhan132@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Full name of responsible person
Dr. Sobhan Sobhani
Position
Assistant Professor, PT, PhD
Other areas of specialty/work
Street address
Chamran Blvd. Abiverdi1 avenue, School of Rehabilitation Sciences
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
sobhan132@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Full name of responsible person
Dr. Sobhan Sobhani
Position
Assistant Professor, PT, PhD
Other areas of specialty/work
Street address
Chamran Blvd. Abiverdi1 avenue, School of Rehabilitation Scienc
City
shiraz
Postal code
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
sobhan132@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)