The objective of this randomized trial is to investigate the acute and residual effects of Whole Body Vibration on balance in type II diabetic patients. In this study 30 subjects who meet the inclusion/exclusion criteria will be recruited and randomly assigned into one of the 2 intervention or control groups. The subjects in the intervention group will receive WBV. The subjects in control group will receive no intervention. Intervention lasts for 4 weeks. Static and dynamic balance indicators of all participants will be measured before intervention, immediately after and 1 month after the intervention, and will be compared between 2 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404064203N7
Registration date:2014-04-12, 1393/01/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-04-12, 1393/01/23
Registrant information
Name
Atefeh Aminian Far
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4180
Email address
aminianfar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Semnan University of Medical Sciences
Expected recruitment start date
2014-04-20, 1393/01/31
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the acute and residual effects of Whole Body Vibration on balance in type II diabetic patients.
Public title
diabetes and balance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Diagnosis of type 2 diabetes by a physician
2. Presence of impaired balance while standing through force plate examination
3. Being between 40 – 60 years old
Exclusion criteria:
1. Having diabetic foot ulcer
2. Having orthopedic or surgical problems affecting on standing ability
3. Having nondiabetic neuropathy
4. Having other neurological problems
5. Presence of visual disturbances that can not be corrected with glasses
6. Taking drugs with adverse effects on balance system
7. Diseases such as migraine, epilepsy or problems such as menstrual irregularities
8. Implanted metal
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Deputy of Research, Semnan University of Medical Sciences
Street address
Bassij Blvd, Semnan University of Medical Sciences, Deputy of Research, Semnan, Iran.
City
Semnan
Postal code
1439957181
Approval date
2014-03-04, 1392/12/13
Ethics committee reference number
415458/92
Health conditions studied
1
Description of health condition studied
non-insulin dependent diabetes mellitus
ICD-10 code
G59.0
ICD-10 code description
Diabetic mononeuropathy
Primary outcomes
1
Description
Center of pressure displacement magnitude
Timepoint
Before Intervention, 4 weeks following the intervention, 1 month following end of intervention.
Method of measurement
through force plate
2
Description
velocity of center of pressure displacement magnitude
Timepoint
Before Intervention, 4 weeks following the intervention, 1 month following end of intervention.
Method of measurement
through force plate
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Applying WBV 5 times per week during 4 weeks. In the first week WBV would be applied as 2 mm amplitude and 30 Hz frequency through 5 sets of 30 seconds periods with a minute rest between sets. During the next week, WBV would be applied as before except for 45 seconds periods. In last week the duration of WBV would be 1 minutes with a minute rest between periods.
Category
Rehabilitation
2
Description
Control group: no intervention
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar hospital
Full name of responsible person
Dr. Atefeh Aminian Far
Street address
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research, Semnan University of Medical Sciences
Full name of responsible person
Dr. Ali Rashidypour
Street address
Bassij Blvd, Semnan University of Medical Sciences, Deputy of Research, Semnan, Iran.
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences
City
Semnan
Postal code
1439957181
Phone
+98 23 1335 4182
Fax
Email
aminfar@sem-ums.ac.iraminfar83@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences
City
Semnan
Postal code
1439957181
Phone
+98 23 1335 4182
Fax
Email
aminfar@sem-ums.ac.iraminfar83@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences
City
Semnan
Postal code
1439957181
Phone
+98 23 1335 4182
Fax
Email
aminfar@sem-ums.ac.iraminfar83@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)