Aim: Effects of WBV on diabetic type 2 patients with neuropathy. Design and intervention: Twenty diabetic type 2 patients with neuropathy will be divided to control and intervention groups in this study. Intervention group will receive WBV for 6 weeks twice a week. Inclusion criteria: BMI between 25 and 35- age between 50 and 70; mild (7-12) to moderate (13-29) neuropathy according to MDNI. Exclusion criteria: visual disturbances; epilepsy; umbilical or abdominal herniation; kidney or bladder stone; and severe cardio pulmonary disease. After treatment course balance and strength factors will be compared between study groups.
General information
Acronym
WBV= whole body vibration
IRCT registration information
IRCT registration number:IRCT201106156806N1
Registration date:2011-06-27, 1390/04/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-27, 1390/04/06
Registrant information
Name
Amin Kordi Yoosefinejad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7762 9011
Email address
yoosefinejad@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rehabilitation Faculty- Diabetes and Metabolic disorders Research Centre
Expected recruitment start date
2011-04-30, 1390/02/10
Expected recruitment end date
2011-10-22, 1390/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Whole Body Vibration on balance of diabetic type2 patients' neuropathy.
Public title
Effect of ٍٍExercise Therapy on Diabetes type2
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being a case for diabetes type 2; Body Mass Index between 25 to 35 and mild to moderate neuropathic involvement according to MNSI
Exclusion criteria:
Visual disturbances; Epilepsy; Umbilical, abdominal or disc herniation; acute infection; fracture or sprain for recent 6 weeks; migraine; kidney or bladder stone; severe cardio vascular disease; regular exercise; severe osteoporosis and dDrugs affecting balance
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rehabilitation Faculty Ethics Committee
Street address
Piche shemiran
City
Tehran
Postal code
Approval date
2011-02-07, 1389/11/18
Ethics committee reference number
260/621
Health conditions studied
1
Description of health condition studied
Diabetic Mellitus type 2 with Peripheral neuropathy
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Balance- Specific and General muscle strength
Timepoint
6 weeks
Method of measurement
Force Plate- Dynamometer- Chest Back Leg Apparatus
Secondary outcomes
1
Description
Blood profiles including FBS, HbA1C,TG, Cholestrol
Timepoint
6 weeks
Method of measurement
Blood Routine Tests:Blood sample( 5 cc) from antebrachial vein before breakfast
Intervention groups
1
Description
Control group: patients do not recieve any treatment during this 6 weeks.
Category
N/A
2
Description
Intervention Group: patients recieve WBV for 6 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation Faculty of TUMS- Diabetes and Metabolic disorders research centre
Full name of responsible person
Dr Mohajeri Tehrani
Street address
Shariaati hospital- Metabolic and Endocrine diseases centre
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rehabilitation Faculty of TUMS- Diabetes and Metabolism disorders Cenre
Full name of responsible person
Amin Kordi Yoosefinejad
Street address
Rehabilitation Facuclty of Teran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rehabilitation Faculty of TUMS- Diabetes and Metabolism disorders Cenre
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
Rehabilitation Faculty
Full name of responsible person
Amin Kordi Yoosefinejad
Position
PhD student of Physical Therapy
Other areas of specialty/work
Street address
piche shemiran, Rehabilitation Faculty
City
Tehran
Postal code
Phone
+98 21 7762 9011
Fax
Email
yoosefinejad@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rehabilitation Faculty of Tehran University of Medical Sciences
Full name of responsible person
Azade Shadmehr
Position
PhD of Physical Therapy
Other areas of specialty/work
Street address
piche shemiran, Rehabilitation Faculty
City
Tehran
Postal code
Phone
+98 21 7753 0670
Fax
Email
shadmehr@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rehabilitation Faculty of Tehran University of Medical Sciences