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Comparison of the effect of 6 weeks selected lower limb muscles strength and endurance training on gait parameters in diabetic patient with peripheral neuropathy.

Protocol summary

Study aim
Comparison of the effect of 6 weeks selected lower limb muscles strength and endurance training on gait parameters in diabetic patient with peripheral neuropathy.
Design
The clinical trial has 3 groups, including the endurance training group, the strength training group and the control group. The method of simple randomization is by lottery to enter the strength, endurance and control group.
Settings and conduct
Walking parameters are collected using the Force plate device of Faculty of Physical Education and Sports Sciences of rasht. The patients undergo therapeutic exercises for 18 sessions at Rasht razi hospital University. No treatment is performed in the control group for six weeks. After the training period, the parameters are collected again.
Participants/Inclusion and exclusion criteria
The inclusion and exclusion criteria include obtaining a score higher than 7 in the Michigan Questionnaire, adequate muscle strength in the knee and ankle muscles, age between 45 and 65, body mass index between 18.5 and 25.5, absence of diabetic foot ulcers, absence of musculoskeletal disorders that cause walking disorder, the absence of severe cardiovascular disease.
Intervention groups
Patients are evaluated by a physiotherapist and according to the inclusion criteria, they are randomly divided into three groups: strength training, endurance training and control group. The strength training group performs strength training for 6 weeks (18 sessions, 3 non-consecutive days per week) and the endurance training group performs endurance training for 6 weeks (18 sessions, 3 non-consecutive days per week) under the supervision of a physiotherapist And no training intervention is done during these 6 weeks in the control group.
Main outcome variables
Improving balance while walking and reducing the risk of falling by increasing muscle strength in patients with diabetic neuropathy.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231201060233N1
Registration date: 2024-07-14, 1403/04/24
Registration timing: registered_while_recruiting

Last update: 2024-07-14, 1403/04/24
Update count: 0
Registration date
2024-07-14, 1403/04/24
Registrant information
Name
Saleh Ashrafi
Name of organization / entity
The University of Tarbiat Modares
Country
Iran (Islamic Republic of)
Phone
+98 13 4262 3088
Email address
saleh.ashrafi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of 6 weeks selected lower limb muscles strength and endurance training on gait parameters in diabetic patient with peripheral neuropathy.
Public title
Comparison of the effect of 6 weeks selected lower limb muscles strength and endurance training on gait parameters in diabetic patient with peripheral neuropathy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index between 18.5 and 25.5 A score of at least 4 in the manual muscle test of the knee and ankle muscles. Getting a score less than 13 in the Timed up and Go test Approval of the written consent form to participate in the study Not having a regular exercise program in the last year Fasting blood sugar should be controlled between 80 and 120 before sports interventions. The amount of glycosylated hemoglobin (HbA1c) is less than 9 and at least 6.5 Obtaining a score higher than 7 in the Michigan Questionnaire
Exclusion criteria:
Existence of musculoskeletal disorders (back pain, knee pain, etc.) that lead to impaired walking. Presence of accompanying orthopedic and neurological diseases such as stroke, cerebral palsy, poliomyelitis, rheumatoid arthritis, prosthesis Existence of severe cardiovascular disease such as arteriovenous ulcers and acute heart disease, cardiac autonomic arrhythmia Presence of diabetic foot ulcer
Age
From 45 years old to 65 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
The method of randomization is simple and individual. People are asked to choose a number between zero, one and two, and according to their choice, they are placed in one of 3 groups.
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 Tarbiat Modares University
Street address
Tarbiat modares university, Nasr bridge,Jalal al ahmad street, tehran
City
Tehran
Province
Tehran
Postal code
1411511111
Approval date
2023-04-29, 1402/02/09
Ethics committee reference number
IR.MODARES.REC.1402.010

Health conditions studied

1

Description of health condition studied
Diabetic neuropathy disease
ICD-10 code
E10.40
ICD-10 code description
Type 2 diabetes mellitus with diabetic neuropathy, unspecified

Primary outcomes

1

Description
Walking parameters include ground reaction force (first peak and second peak), center of pressure (anterior-posterior and internal-external displacement), fear of falling, walking time.
Timepoint
The parameters are measured at the beginning of the study and after 6 weeks.
Method of measurement
Walking parameters include ground reaction force and center of pressure using force plate device, fear of falling using fall efficiency scale-international questionnaire and walking time using Timed get and go test questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: includes the strength training group. The strength training group performs strength training using leg press and leg curl under the supervision of a physiotherapist for 6 weeks (18 sessions, 3 non-consecutive days per week).
Category
Rehabilitation

2

Description
Intervention group 2: It includes the endurance training group. The endurance training group performs endurance training using Leg press and Leg curl under the supervision of a physiotherapist for 6 weeks (18 sessions, 3 non-consecutive days per week).
Category
Rehabilitation

3

Description
Control group: no intervention is done during 6 weeks in the control group. Based on the ethical standards, after 6 weeks, the participants in the control group will be provided with an exercise therapy protocol.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Medical Education Center
Full name of responsible person
Seyed Saleh Ashrafi
Street address
Razi Medical Education Center, Defenders of Health Boulevard, Rasht
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3355 9787
Email
Razi.hospital@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fathollahi Yaghoub
Street address
No 7, Jalal Al Ahmad street
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2009
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
Tarbiat Modares University
Full name of responsible person
Seyed Saleh Ashrafi
Position
Physical Therapy PHD student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Razi hospital, Modafean salamat BLvd
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3354 1001
Email
saleh.ashrafi@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Bahrpeyma Farid
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Jalal Al Ahmad street, Nov7
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3819
Email
bahrpeyf@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Seyed saleh Ashrafi
Position
physical Therapy PHD Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Razi hospital, Modafean salamat Blvd
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3354 1001
Email
saleh.ashrafi@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
Data related to walking parameters and data related to questionnaires are shared after deidentifying people.
When the data will become available and for how long
Access starts 3 months after the publication of the article extracted from the research.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers are allowed to use documents that are related to their research topic and simple statistical analyzes are allowed.
From where data/document is obtainable
Communication via Seyed Saleh Ashrafi's email: saleh.ashrafi@modares.ac.ir
What processes are involved for a request to access data/document
The request is sent via email, and if the subject of the research is related, the documents will be provided to the individual within 10 days at the latest.
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