The aim of this study is investigating the effect of whole body vibration on ankle joint proprioception and balance in diabetic neuropathy patients.
Design
The clinical trial is included a control group and a sample size of 26 persons that are assigned to either intervention or control group with regard to random number table.
Settings and conduct
This study will be carried out at the Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences. The intervention group is progressively undergoing WBV twice a week for 6 weeks.Both in the intervention group and in the control group static and dynamic balance and ankle proprioception are measured by Biodex System at the beginning of the study and after the first session and after 6 weeks of intervention and one month after the end of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Having diabetes that lasts at least 5 years from their diabetes.
Age 40 to 65 years؛
Exclusion criteria:
Having a diabetic wound in the foot
Internal ear disorder
Neurology and rheumatology diseases
Severe osteoarthritis in the lower limb joints
Intervention groups
Intervention group (whole body vibration): undergo whole body vibration progressively 2 times a week for 6 weeks.
Control group: They are matched with the intervention group regarding to age, duration of diabetes and severity of neuropathy and do not receive any intervention.
Main outcome variables
Static stability index؛ dynamic stability index؛ functional balance؛ ankle reconstruction error from a reference angle.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191109045369N1
Registration date:2019-12-09, 1398/09/18
Registration timing:prospective
Last update:2019-12-09, 1398/09/18
Update count:0
Registration date
2019-12-09, 1398/09/18
Registrant information
Name
Hamed Manafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3444 6616
Email address
hamedmanafi3654@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of whole body vibration on ankle joint proprioception and balance in diabetic neuropathy patients
Public title
whole body vibration and diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having diabetes that lasts at least 5 years.
Age 40 to 65 years
BMI 22-30 kg / m2
Earning the score above 2 on the basis of questionnaire on diabetic neuropathy test scale of the University of Göringen in Netherlands that means existence of diabetic neuropathy.
Exclusion criteria:
Having a diabetic wound in the foot
Internal ear disorder
History of ankle dislocation and charcot joint
Neurology and rheumatology diseases
Severe osteoarthritis in the lower limb joints
Visual disorders
Vertigo
Participation in balance, resistance or endurance exercise programs in the last year
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization is applied by using the random number table. Individuals with diabetic neuropathy are voluntarily recruited to the study and after completing the consent form are included in the study by matching with inclusion and exclusion criteria.Then each participant is devoted a number and the numbers are given to an assignment expert. The expert uses random number table to put individuals into two groups, intervention (whole body vibration) or control group.
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
Ethics committee of Semnan University of Medical Sciences
Street address
Ethics committee of Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2019-11-19, 1398/08/28
Ethics committee reference number
IR.SEMUMS.REC.1398.206
Health conditions studied
1
Description of health condition studied
Diabetic Neuropathy
ICD-10 code
E08.40
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified
Primary outcomes
1
Description
Static stability index in anteroposterior, mediolateral and overal axes
Timepoint
At the beginning of the study, after the first session, after 6 weeks of intervention and one month after the end of intervention in both groups.
Method of measurement
Based on Biodex Balance System (millimeter)
2
Description
Dynamic stability index in anteroposterior, mediolateral and overal axes
Timepoint
At the beginning of the study, after the first session, after 6 weeks of intervention and one month after the end of intervention in both groups.
Method of measurement
Based on Biodex Balance System(milimeter)
3
Description
Functional balance
Timepoint
At the beginning of the study, after the first session, after 6 weeks of intervention and one month after the end of intervention in both groups.
Method of measurement
Berg Balance score
4
Description
Ankle reconstruction error from a reference angle (proprioception)
Timepoint
At the beginning of the study, after the first session, after 6 weeks of intervention and one month after the end of intervention in both groups.
Method of measurement
Based on Biodex System (degree)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They receive whole body vibration (WBV) progressivly 2 times a week for 6 weeks.In the first week, WBV with 30 Hz frequency, 2mm amplitude is applied five times for 30 seconds , with 1 minute rest between periods. During the following week, the frequency and amplitude are kept the same, but the WBV change to five times for 45 seconds, with 1 minute rest between periods. During the last week, the patient undergoes WBV five times for 1 minute, with 1 minute rest between periods.
Category
Rehabilitation
2
Description
Control group: They do not receive any intervention. In this group, all subjects will be evaluated for static and dynamic balance and proprioception before beginning the study, after the first session, after 6 weeks of intervention and one month after the end of intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Atefe Aminian Far
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Sq
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
aminfar83@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Atefe Aminian Far
Street address
Semnan University OF Medical Science, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Fax
+98 23 3344 8999
Email
info@semums.ac.ir
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Atefe Aminian Far
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Sq
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
aminfar@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Atefe Aminian Far
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Sq
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
aminfar@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hamed Manafi
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Sq
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
hamedmanafi3654@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
It will only be available to researchers working in academic institutions.
Under which criteria data/document could be used
If there are any relevant studies
From where data/document is obtainable
Atefe Aminian Far.
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Sq
Tel: 0098 23 33654180
Postal code: 3513138111
What processes are involved for a request to access data/document