1. Home
  2. Approved trials
  3. » فارسی

Study of the Effect of Local Vibration on Balance, Protective and Vibration Sensation, Pain and Foot Temperature in Patients with Diabetic Neuropathy (before-After Clinical Trial)

Protocol summary

Study aim
To examine the effect of local foot vibration on balance, sense (protective and vibration), foot pain and foot temperature in patients with diabetic neuropathy
Design
Befor-after clinical trial, lacking control group
Settings and conduct
12 Diabetic neuropathy Patients whose neuropathy was confirmed by the physician,were referred to physiotherapist from the Diabetes Center and the Metabolic Diseases of Tehran University of Medical Sciences . All assessment was done before, immediately after and after 5th session of therapy for both feet. Demography data such as age, gender, duration of disease, type of medication that patients taken, was recorded by physiotherapist. intervention was done in rehabilitation center of Shariati hospital by physiotherapist. data analysis was performed using ANOVA and Bonferroni in SPSS software version 22.
Participants/Inclusion and exclusion criteria
Inclusion criteria 1-Patient with diabetic neuropathy to diagnose a doctor (Michigan score of 4 and above) 2-Age between 50-70 3-Ability to walk independently Exclusion criteria 1-Inability to complete balance test 2-Dissatisfaction to continue the plan 3-wound in the plantar side of the foot 4-charico joint 5-suffering from other neurological disease
Intervention groups
The patient was left in crook lying with no shoes and socks on the bed and placed one pillow under the knees so that the knees are comfortable on them. Both of the feet placed on vibrator and a local vibration with a frequency of 62.5 Hz for 10 minutes was applied to the plantar side of both feet. The device was placed on the platform, which was separated from the bed. Patients referred for the five sessions a day in between, for treatment.
Main outcome variables
Balance(brief-BEST test), protective sensation (monofilament), vibration sensation(tunning fork), temperature(thermometer), pain(NPRS)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190414043268N1
Registration date: 2020-06-05, 1399/03/16
Registration timing: retrospective

Last update: 2020-06-05, 1399/03/16
Update count: 0
Registration date
2020-06-05, 1399/03/16
Registrant information
Name
mahsa sabziparvar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4497 7014
Email address
m_sabziparvar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
2019-08-11, 1398/05/20
Actual recruitment end date
2019-10-12, 1398/07/20
Trial completion date
2019-10-12, 1398/07/20
Scientific title
Study of the Effect of Local Vibration on Balance, Protective and Vibration Sensation, Pain and Foot Temperature in Patients with Diabetic Neuropathy (before-After Clinical Trial)
Public title
Study of the effect of local vibration on diabetic neuropathy symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having Diabetic neuropathy based on physician diagnosis (Michigan score 4 and above) Age between 50-70 Ability to walk independently
Exclusion criteria:
Wound on plantar area of foot Charcot joint Suffering from other neurological disease
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: 12
Actual sample size reached: 12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of nursing and midwifery and rehabilitation Schools of Tehran University of Medical
Street address
Ghods Ave, Keshavarz blv
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.TUMS.FNM.REC.1398.060

Health conditions studied

1

Description of health condition studied
Diabetic polyneuropathy
ICD-10 code
E08.42
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic polyneuropathy

Primary outcomes

1

Description
Score of Balance Test
Timepoint
Before, at the end of the first and fifth session
Method of measurement
Brief balance evaluation system test (brief-BEST)

2

Description
Protective sensation
Timepoint
Before, at the end of the first and fifth session
Method of measurement
Monofilament (5.07)

3

Description
Threshold of vibration sensation
Timepoint
Before, at the end of the first and fifth session
Method of measurement
Rydel-Seiffer tuning fork (128 Hz)

4

Description
Foot temperature
Timepoint
Before, at the end of the first and fifth session
Method of measurement
Manual- digital thermometer

5

Description
The status of vibration sensation
Timepoint
Before, at the end of the first and fifth session
Method of measurement
Tuning fork (128 Hz)

6

Description
Pain
Timepoint
Before, at the end of the first and fifth session
Method of measurement
Numerical pain rating scale (NPRS)

Secondary outcomes

empty

Intervention groups

1

Description
The patients was left in crook lying with no shoes and socks on the bed and placed one pillow under the knees so that the knees are comfortable on them. Average room temperature was set to 25 °. Both of the feet placed on vibrator and a local vibration with a frequency of 62.5 Hz for 10 minutes was applied to the plantar side of both feet. The device was placed on the platform, which was separated from the bed. Patients referred for the five sessions a day in between, for treatment.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes and Metabolic Disease Center
Full name of responsible person
Dr Neda Mehrdad
Street address
Diabetes and Metabolic Disease Center, first cross road, Shahrivar street, North Kargar
City
Tehran
Province
Tehran
Postal code
1411715851
Phone
+98 21 8833 4192
Email
emri-diabetes@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Science
Full name of responsible person
Dr Masood younesian
Street address
Vice chancellor for research and technology of Tehran University of Medical Science, Sixth floor, university central office, at the corner of Qods street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
417653761 1
Phone
+98 21 8163 3698
Fax
+98 21 8163 3654
Email
rcco@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tehran University of Medical Science
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
Department of Physiotherapy, School of Rehabilitation ,Tehran University of Medical Science
Full name of responsible person
Mahsa Sabziparvar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Department of physiotherapy ,School of Rehabilitation , Pitch-e-Shemiran, Enghelab Ave
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 5132
Email
sabziparvarm@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Physiotherapy ,School of Rehabilitation ,Tehran University of Medical Science
Full name of responsible person
Mahsa Sabziparvar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Department of Physiotherapy ,School of Rehabilitation ,Pitch-e-Shemiran, Enghelab Ave
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
sabziparvarm@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Department of Physiotherapy,School of Rehabilitation , Tehran University of Medical Science
Full name of responsible person
Mahsa Sabziparvar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Department of Physiotherapy ,School of Rehabilitation , Pich-e-Shemiran, Enghelab Ave
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 4133
Email
sabziparvar@yahoo.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
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only a part of the data that is related to the original outcome can be shared.
When the data will become available and for how long
Start of access period after printing results
To whom data/document is available
Medical Academic researchers
Under which criteria data/document could be used
No analytical is allowed on the data delivered.
From where data/document is obtainable
To receive data or documents connect with email sabziparvarm@yahoo.com or address: enghelab street-Piche-e-shemiran- rehabilitation faculty-physiotherapy department mahsa sabziparvar tel:09187133422
What processes are involved for a request to access data/document
After receiving the requested email, it will be answered.
Comments
Loading...