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Immediate effect of vibrating sandal in swing phase of gait on postural indices and lower limb muscles activity in patients with moderate diabetic neuropathy compared with age-matched controls

Protocol summary

Study aim
Immediate effect of vibrating sandal on people with diabetic peripheral neuropathy
Design
Before-after clinical trial including normal control and intervention group (No randomisation). 10 normal control, 15 Diabetic
Settings and conduct
Biomechanical and gait laboratory of Tarbiat Modares University
Participants/Inclusion and exclusion criteria
elderly patients aged between 50-75 diagnosed with moderate diabetic peripheral neuropathy. no insulin treatment. no history of cardiovascular or lung disease, neurological disease, rheumatoid arthritis, severe osteoarthritis problem. Michigan neuropathy screening instrument (MNSI) score between 13-29. right dominant side. no severe retinopathy. lower limb muscles score based on manual muscle testing must be 4 (hip, knee and ankle muscles). normal range of motion in joints. Hba1c score between 6.5 - 9. no diabetic foot ulcer. no history of falling accidentally. no partnership in any kind of WBV training and exercise therapy course over last year. no interest to continue in this study.
Intervention groups
intervention group are elderly patients aged 50 to 75 diagnosed with moderate diabetic peripheral neuropathy who suffer from peripheral nervous system disorder which lead to balance deficiency and muscle disorder. in order to evaluate the effect of vibration on foot sole through wearing vibrating sandal and 10 minuets walking and at the end measuring the dynamic balance factors and muscles function. control group is healthy and the same age people with intervention group.
Main outcome variables
Sit to stand and Turn dynamic balance tests of Mars software: Center of pressure sway; cop sway velocity; cop sway path, Reaction time; Movement velocity; Median frequency; Weight transfer ; Turn time; Turn sway Lower limb muscles function and activation: Mean actual error; SD of absolute error; maximum voluntary isometric contraction; Root mean square

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181108041593N1
Registration date: 2020-02-01, 1398/11/12
Registration timing: registered_while_recruiting

Last update: 2020-02-01, 1398/11/12
Update count: 0
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
Niloofar Eslami ghelichi
Name of organization / entity
The University of Tarbiat Modares
Country
Iran (Islamic Republic of)
Phone
+98 21 7670 1860
Email address
n.eslami@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-07, 1398/07/15
Expected recruitment end date
2020-02-04, 1398/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Immediate effect of vibrating sandal in swing phase of gait on postural indices and lower limb muscles activity in patients with moderate diabetic neuropathy compared with age-matched controls
Public title
Effect of Vibration on dynamic balance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non insulin diabetic patients Diabetic patients with BMI between 25 and 30 Diabetic patients who diagnosed with diabetes between 8 to 12 years Neuropathic diabetic patients with Michigan score between 13 and 29 Diabetic patients with 75-200 mg fast blood sugar in test's day Diabetic patients who get at least 4 minus score in manual muscle test Diabetic patients with normal range of motion in hip, knee and ankle joints Diabetic patients with less than 9 and more than 5/6 Hba1c Diabetic patients with less than 140/90 and more than 100/70 blood pressure and less than 100 heart beat before starting tests Diabetic patients with right dominant side Diabetic patients with normal skin temperature in plantar surface, 30.6±2.6
Exclusion criteria:
Special drug usage that interfere patient's balance Rhetinopathy and severe visual dysfunction Routine smoking and alcohol consumption History of unexpected falling Diabetic foot ulcer WBW trainings during recent one year Pes planus, Knee varus and valgus, severe kyphosis Postural hypotension Participating in regular physical, balance or resistance exercise program Pain, inflammation and swelling or severe arthrosis in lower limb joints Pain in mild and moderate osteoarthritic joints during previous one month Patient willingness to quit the research Orthopedic, nourologic diseases like stroke, parkinson, cerebral paralysis, poliomyelis, rheumatoid arthritis, prostheis, uncontrolled hypertension, severe cardiovascular disease such as severe coronary ischemia, acute cardiac disease and caridac arhythmia
Age
From 50 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 25
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University of Medical Sciences
Street address
No. 7, Nasr, Jalal AleAhmad Ave
City
Tehran
Province
Tehran
Postal code
14115111
Approval date
2019-03-03, 1397/12/12
Ethics committee reference number
IR.MODARES.REC.1397.265

2

Ethics committee
Name of ethics committee
Ethics committe on medical researches of Tarbiat Modares university
Street address
Jalal, Ale-Ahmad, Nasr
City
Tehran
Province
Tehran
Postal code
14111-115
Approval date
2019-03-02, 1397/12/11
Ethics committee reference number
IR..MODARES.REC.1397.265

Health conditions studied

1

Description of health condition studied
Diabetic peripheral neuropathy
ICD-10 code
E11.40
ICD-10 code description
Type 2 diabetes mellitus with diabetic neuropathy,

Primary outcomes

1

Description
Sit to stand and Turn dynamic balance tests of Mars software.
Timepoint
Immediately before and Immediately after functional task
Method of measurement
Dynamic balance tests by Kistler Mars Software

2

Description
Lower limb muscles function and activation
Timepoint
Immediately Before and Immediately after functional test
Method of measurement
Electromyography

Secondary outcomes

empty

Intervention groups

1

Description
Moderate diabetic neuropathy patients will use vibrating sandal in swing phase of walking.
Category
Diagnosis

2

Description
Control group: Matched normal subjects who same as diabetic group tested by vibration sandal.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Tarbiat Modares University
Full name of responsible person
Roya ravanbod
Street address
No. 7, Nasr, Jalal AleAhmad Ave
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 82880
Fax
+98 21 8800 6544
Email
royaravanbod@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The university of Tarbiat Modares
Full name of responsible person
Yaghoub Fathollahi
Street address
Jalal al ahmad street, nasr bridge, Tarbiat modares University, physiotherapy faculty, room No 225
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 4510
Fax
+98 21 8800 7598
Email
fatolahi@modares.ac.ir
Web page address
https://www.modares.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tarbiat modares University
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
The University of Tarbiat Modares
Full name of responsible person
Niloofar Eslami ghelichi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 120, east 180 Ave., Tehranpars., Tehran
City
Tehran
Province
Tehran
Postal code
1655944687
Phone
+98 21 7670 1860
Fax
Email
n.eslami@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Niloofar Eslami ghelichi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 120, east 180 Ave., Tehranpars., Tehran
City
Tehran
Province
Tehran
Postal code
1655944687
Phone
+98 21 7670 1860
Fax
Email
n.eslami@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Niloofar Eslami ghelichi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 120, east 180 Ave., Tehranpars., Tehran
City
Tehran
Province
Tehran
Postal code
1655944687
Phone
+98 21 7670 1860
Fax
Email
n.eslami@modares.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the data will be shared after getting subject's identity indiscernible
When the data will become available and for how long
six months after results publishing
To whom data/document is available
people with activity in academic and scientific environment
Under which criteria data/document could be used
Data would be useful and effective for diabetic neuropathy patients in order to increase the somatosensory feedback. Therefore, vibrating sandal could positive influence their functional dynamic daily living tasks.
From where data/document is obtainable
Doctor Roya Ravanbod. email: rravanbod@hotmail.com tel: 02182884510
What processes are involved for a request to access data/document
After the permission of vice chancellor of research of Tarbiat Modares university, the data could be available. This procedure might take about two months.
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