Investigating the effect of intermittent pneumatic compression therapy on the kinetic parameters of gait in diabetic patients with neuropathy
Design
In this study, we will have an intervention group and a control group that will be identical. The sample size of each group will be at least 15, and the applicants will be randomly divided into two groups using the table of random numbers.
Settings and conduct
At first, type 2 diabetic patients will enter the study according to the inclusion and exclusion criteria, and after primary assessments, they will receive intervention for 10 sessions, and then they will be evaluated and compared with the primary results. the location of the project will be in Karaj.
Participants/Inclusion and exclusion criteria
1- People with type 2 diabetes.
2- 5 to 15 years have passed their diabetes.
3- People in the age range of 40 to 75 years.
4- Fasting blood sugar should be 120-250
5- The patient's blood pressure should be at least 100/60 mmHg and maximum 40/140 mmHg.
6- HbA1c between 6/5-9%.
7 - People with symptoms of moderate diabetic sensory neuropathy.
8. To show neuropathy, Proneal and Tibial nerves motor NCV be lower than 40 m/s.
9- People have the ability to walk without the need for assistive devices.
10 - People have the ability to participate in the study and communication with the therapist.
11- People with independent life and visual acuity should prevail in the eyes at least in proportion to 20/40.
Intervention groups
The intervention group will undergo 10 sessions of intermittent pneumatic compression therapy for 45 minutes. During these 10 sessions, the control group will not receive any intermittent pneumatic compression therapy and balance training.only took their usual medications (including those that will not affect the vascular system).
Main outcome variables
Changes in the kinetic parameters of gait
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190417043299N2
Registration date:2020-04-27, 1399/02/08
Registration timing:prospective
Last update:2020-04-27, 1399/02/08
Update count:0
Registration date
2020-04-27, 1399/02/08
Registrant information
Name
Seyed Ahmad Bagherian
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3207
Email address
a.bagherian@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-02, 1399/02/13
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of intermittent pneumatic compression therapy on the kinetic parameters of gait in diabetic patients with neuropathy
Public title
effect of intermittent pneumatic compression on diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetic patients with 5 to 15 years disease duration
Fasting blood sugar should be 120-250.
The patient's blood pressure should be at least 100/60 mmHg and below 140/190 mmHg.
Hb A1c between 6.5 - 9%.
applicants have moderate diabetic sensory neuropathy symptoms.
age between 40-75 years
Exclusion criteria:
Patients with non-diabetic neuropathy and rheumatoid patients.
Patients who smoke, smoke hookah and drink alcohol.
People with heart disease or have a history of orthopedic surgery.
Patients with venous thrombosis.
Patients with limited range of motion of the lower extremities.
Patients with edema in the lower extremities.
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
A random numbers table will be used to randomize the grouping. In this way, the applicants to whom the odd numbers are assigned will enter the intervention group and the applicants to whom the even numbers will be assigned will enter the 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
Committee of Ethics in Research at Tarbiat Modares university
Street address
Tarbiat Modares University, Jalal-Al-Ahmad St.
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2015-11-22, 1394/09/01
Ethics committee reference number
5747/د52
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11.40
ICD-10 code description
Type 2 diabetes mellitus with diabetic neuropathy, unspecified
Primary outcomes
1
Description
Kinetic parameters of gait Clinical evaluation and comparison before and after treatment
Timepoint
Before intervention and after 10 treatment sessions
Method of measurement
Force plate device and evaluation of vibration sense by diapason
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After the primary assessments, the intervention group will undergo 10 treatment sessions by intermittent pneumatic compression . During this period, the group will also receive their usual medication.
Category
Rehabilitation
2
Description
Control group: Control group: During these 10 sessions, the control group will not receive any intermittent pneumatic compression therapy or balance training and will only take their usual medications (except those that affect the vascular system).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Mahdi Dehghani specialized clinic
Full name of responsible person
Mahdi Dehghani Mohammad Abadi
Street address
خیابان شهید بهشتی، جنب ساختمان شهر کتاب، ساختمان پزشکان نور، طبقه ی ۴، واحد ۱۵
City
Karaj
Province
Alborz
Postal code
3144716458
Phone
+98 26 3421 6009
Email
mehdidehghani52@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Yaaghoub Fath Allahi
Street address
The University of Tarbiat Modares, Jalal-Al-Ahmad St.
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3101
Email
Res@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Seyed Ahmad Bagherian
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
The university of Tarbiat Modares, Jalal-Al-Ahmad St.
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3590
Fax
Email
a.bagherian@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Farid Bahrpeyma
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
The University of Tarbiat Modares, Jalal-Al-Ahmad
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3590
Email
bahrpeyf@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Seyed Ahmad Bagherian
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
The university of Tarbiat Modares, Jalal-Al-Ahmad St.
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3590
Fax
Email
a.bagherian@modares.ac.ir
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
All information can be shared after making the subjects unidentifiable.
When the data will become available and for how long
6 months after publication of results
To whom data/document is available
All individuals can use information about the results of the study.
Under which criteria data/document could be used
To treat diabetic patients and to carry out new research in this field, data can be used with unidentifying individuals of the study.
From where data/document is obtainable
They can contact the researcher by email They can meet the Physical Therapy Department of Tarbiat Modares University
What processes are involved for a request to access data/document
The requestor should explain the cause of the need for the data clearly and if the reasons are convincing, the data will be available to him.