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kinetics, kinematics, and electromyography parameters of gait with the applied reaction forces on the foot in the diabetic patient and control group

Protocol summary

Summary
One of the most common metabolic disorders is diabetes. Various factors such as life style, nutrition are effect on rapid prevalence. Currently, more than 7 million people have diabetes in Iran. Until 2035, world diabetes prevalence expects to reach 592 million. Diabetes associated with functional alteration (neuropathy, decreased range of motion joints, vasculopathy) and structural alteration (foot deformities, skin changes, and muscle atrophy) in the foot. Gait strategy in diabetes patient is conservative. This means that the speed of gait was reduced, width of the base of support was increased, and support phase time and stride time were prolonged. Horizontal and vertical reaction forces of the diabetic patients were less and more than that healthy subject respectively. Aim of this study is the evaluation of reaction force, moment, and muscle activity on the lower limb during in females' diabetic and healthy subjects. After careful examination, we will choose 45 females with same demographic characteristic. We are going to use four VICON cameras (200 Hz), two Kistler force plates (1000 Hz), and BTS Free EMG 300 at same time. We will use special software for extracting date. Finally, results will have analyzed with SPSS software.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016112331058N1
Registration date: 2017-03-13, 1395/12/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-13, 1395/12/23
Registrant information
Name
Hananeh Younesian
Name of organization / entity
Bu-Ali Sina University
Country
Iran (Islamic Republic of)
Phone
+98 912 473 1015
Email address
h.younesian@basu.ac.ir
Recruitment status
Recruitment complete
Funding source
institution
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
kinetics, kinematics, and electromyography parameters of gait with the applied reaction forces on the foot in the diabetic patient and control group
Public title
Effect of diabetes on biomechanal factors of gait
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Diabetes type II, lack of acute problems in heart, vision, Kidney Exclusion criteria: Fracture history, diabetic ulcer
Age
From 25 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
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
Hamedan university of medical science
Street address
Khaje Rashid st. Ayatolah Kashany Av. Hamedan university of medical science
City
Hamedan
Postal code
Approval date
2017-01-14, 1395/10/25
Ethics committee reference number
IR.UMSHA.REC.1395.469

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E10-E14
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
kinematic, Kinetic and electromyography
Timepoint
after 6 months of ending screening
Method of measurement
VICON system, force plate and Surface EMG

2

Description
Neuropathy
Timepoint
pre-intervention
Method of measurement
questionnaire

Secondary outcomes

1

Description
Comparison of diabetes' effect on the biomechanic's gait
Timepoint
After 4 months of assembling data with mentioned devices
Method of measurement
Special software of the each device

Intervention groups

1

Description
Massage Therapy
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Hami Health and diabetes clinic
Full name of responsible person
Dr. Nasrin Khorami
Street address
Jahad st., Nazari Av., Hoveizeh Av.
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
Dr. Nader Farahpour
Street address
Ahmadi Roshan st. Bu-Ali Sina University
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bu-Ali Sina University
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
Bu-Ali Sina University
Full name of responsible person
Dr. Nader Farahpour
Position
Professor/ Faculty member of Bu-Ali Sina University
Other areas of specialty/work
Street address
Ahmadi Roshan St. Sport departman, Bu-Ali Sina university
City
Hamedan
Postal code
Phone
+98 81 3838 1601
Fax
Email
naderfarahpour1@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bu-Ali Sina Univerdity
Full name of responsible person
Hananeh Younesian
Position
Ph.D student, Biomechanic, Physical Education
Other areas of specialty/work
Street address
Ahmadi Roshan St. Bu-Ali Sina University
City
Hamedan
Postal code
Phone
+98 81 3838 1601
Fax
Email
younesian.hana@yahoo.com; younesian.ezat@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
Hananeh Younesian
Position
Ph.D student, Biomechanics, Physical Education
Other areas of specialty/work
Street address
Ahmadi Roshan St. Bu-Ali Sina University
City
Hamedan
Postal code
38695-65178
Phone
+98 81 3838 1601
Fax
Email
younesian.hana@yahoo.com; younesian.ezat@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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