Protocol summary

Study aim
Determination of the Effect of Whole-Body Vibration in improving the balance in patients with Type 2 diabetic neuropathy
Design
A randomized, blinded, sham controlled clinical trial design of 32 patients, enrolled between January 2019 and August 2019
Settings and conduct
Whole body therapeutic vibration ,including non-invasive methods, is the improvement of Stability Indexes without Side Effects. This research aimed to determined effect of Whole body vibration therapy on Stability Indexes of People with Peripheral Diabetic Neuropathy in the School of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences. in this study at first visit lower extremity neuropathy in 32 diabetic patients was meseared by clinical examination and Michigan questionnaire then demographic form and conscious consent form completed by the patients. After that their Stability Indexes was measured with Biodex Machine by researcher. In the next stage Whole body vibration is performed for 30 seconds and 6 times with one minute rest every time, and Stability Indexes are re-evaluated
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients aged 40-75 years old with type 2 diabetes and europathy Diagnosis of Type 2 Diabetes, Taking medicine in the form of pills, Michigan test score, between 13-29, HbA1C <8.5%, BMI ranges from 25-35 exclusion criteria: En Infectious diabetic wounds, Neurological diseases and rheumatoid arthritis, balance and vestibular system, visual disturbances, Scarring in the areas of the foot and fingers، Severe pain in the lower extremities during the study, History of trauma, injury and surgery in the waist, Knee or hip prosthesis, Epilepsy and cognitive problems, The presence of psychotic diseases and depression, Active implants
Intervention groups
Vibration therapy
Main outcome variables
Functional Balance Score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180302038912N1
Registration date: 2019-07-09, 1398/04/18
Registration timing: registered_while_recruiting

Last update: 2019-07-09, 1398/04/18
Update count: 0
Registration date
2019-07-09, 1398/04/18
Registrant information
Name
Elnaz Sohrabzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6612 4365
Email address
e.sohrabzadeh88@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The immediate effectiveness of a single session of Whole-Body Vibration in improving the balance in patients with Type 2 diabetic neuropathy
Public title
Effect of Whole-Body Vibration in balance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients aged 40-75 years old with type 2 diabetes and europathy with With the ability to walk independently at least 10 meters without assistance Diagnosis of Type 2 Diabetes Taking medicine in the form of pills, Based on clinical guidelines Michigan test score, between 13-29 (grade of diabetic neuropathy: moderate) HbA1C <8.5% (controlled blood sugar in the last three months) BMI ranges from 25-35
Exclusion criteria:
Infectious diabetic wounds Neurological diseases (other than diabetic neuropathy) and rheumatoid arthritis, balance and vestibular system, visual disturbances Scarring in the areas of the foot and fingers Severe pain in the lower extremities during the study History of trauma, injury and surgery in the waist Knee or hip prosthesis Epilepsy and cognitive problems The presence of psychotic diseases and depression Active implants
Age
From 40 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done using www.randomization.com to assign equal participants in each group (1:1 allocation ). An independent researcher will make random allocation cards using computer-generated random numbers. he will keep the original random allocation sequences until analysis time. Another independent researcher will measure the patients outcome and she will not know the allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were blind about the grouping and assignments. Also group assignment listed were only accessed by study staff following completion of baseline assessments. Statistical analysts were also blind to the groups.
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Arabi Ave., Yaman Ave., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2018-04-09, 1397/01/20
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.1399

Health conditions studied

1

Description of health condition studied
diabetic neuropathy
ICD-10 code
E14
ICD-10 code description
With neurological complication

Primary outcomes

1

Description
balance
Timepoint
Immediately before and after intervention
Method of measurement
Biodex machine

Secondary outcomes

empty

Intervention groups

1

Description
Vibration therapy
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Clinic of School of Rehabilitation Sciences, Shahid Beheshti University of Medical Sci
Full name of responsible person
Elnaz Sohrabzadeh
Street address
Damavand Ave., Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
e.sohrabzadeh88@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mostafa Rezaei Tavirani
Street address
Shahid Arabi Ave., Yaman Ave., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 23871
Email
e.sohrabzadeh88@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elnaz Sohrabzadeh
Position
MSc Physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Damavand Ave., Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
e.sohrabzadeh88@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elnaz Sohrabzadeh
Position
MSc Physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Damavand Avenue., Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
e.sohrabzadeh88@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elnaz Sohrabzadeh
Position
MSc Physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Damavand Ave., Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
e.sohrabzadeh88@gmail.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
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