Investigating the effect of 14-month-old boots compared to unused boots on electromyographic components of lower limb muscles, ground reaction force and plantar pressure during running.
Evaluation the long-term effects of three types of military boot soles on electromyography, ground reaction force and foot pressure variables during running
Design
A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 30 Healthy men
Settings and conduct
This research is semi-experimental and the tests will be conducted in the biomechanics laboratory of Mohaghegh Ardabili University. Participants will participate in two control and intervention groups. There will be 15 people in the intervention group using operational boots with polyurethane, rubber, and urethane soles, and the control group will only test with unused boots. Participants with an average age of 18-25 years will participate, the conditions for entering the study will be the absence of skeletal abnormalities, the absence of corona disease and having a history of using military boots. To observe the electrical activity of the muscles during running, the surface electromyography recording device will be used, and to check the ground reaction force, the force plate device with a sampling frequency of 1000 Hz will be used. This study is a double-blind study.
Participants/Inclusion and exclusion criteria
Thirty healthy subjects, Absence of deformities and injuries in the lower limbs
Intervention groups
Subjects with rubber, TPU, TPU-PU military boots
Main outcome variables
Electromyography activity of the lower limb muscles
Ground reaction forces
Foot pressure variables
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220714055469N1
Registration date:2022-10-22, 1401/07/30
Registration timing:retrospective
Last update:2022-10-22, 1401/07/30
Update count:0
Registration date
2022-10-22, 1401/07/30
Registrant information
Name
Milad Piran hamlabadi
Name of organization / entity
The university of mohaghegh ardabili
Country
Iran (Islamic Republic of)
Phone
+98 45 3344 2424
Email address
miladpiran75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-17, 1401/05/26
Expected recruitment end date
2022-09-17, 1401/06/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of 14-month-old boots compared to unused boots on electromyographic components of lower limb muscles, ground reaction force and plantar pressure during running.
Public title
Investigating the effect of 14-month-old boots compared to unused boots on electromyographic components of lower limb muscles, ground reaction force and plantar pressure during running.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
healthy
Absence of lower limb skeletal abnormalities
Having physical activity
Exclusion criteria:
having a disease
The presence of lower limb skeletal abnormalities
Lack of physical activity
Age
From 18 years old to 25 years old
Gender
Male
Phase
1-2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, the principal investigator, especially in trials initiated by senior academic researchers, those responsible for data collection and those who evaluate the outcome, and those who prepare the draft of the article.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mohsghegh Ardbili university
Street address
Daneshdah Ave., Daneshdah Blvd., Ardabil Town
City
Ardbil
Province
Ardabil
Postal code
56199-13131
Approval date
2022-06-02, 1401/03/12
Ethics committee reference number
IR-UMA.REC.1401.026
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M15.0
ICD-10 code description
Primary generalized (osteo)arthritis
2
Description of health condition studied
Disorders of Knee and Ankle joints
ICD-10 code
M23
ICD-10 code description
Internal derangement of knee
Primary outcomes
1
Description
Ground reaction forces
Timepoint
At the beginning of the study and after 14 months (pre and post training)
Method of measurement
Using force plate system
2
Description
-Muscular electromyography
Timepoint
At the beginning of the study and after 14 months (pre and post training)
Method of measurement
Using electromyography system
Secondary outcomes
1
Description
Co-contraction of lower limbs muscle
Timepoint
At the beginning of the study and after 14 months
Method of measurement
Using EMG system
2
Description
Frequency spectrum of ground reaction force
Timepoint
At the beginning of the study and after 14 months
Method of measurement
Using force plate system
Intervention groups
1
Description
Intervention group: each subject once without using any type of shoes with 3 attempts, once with operational boots with rubber or rubber soles with three attempts, once with polyurethane and rubber boots (two density) with three attempts and once with Polyurethane and thermoplastic polyurethane boot covers the 18-meter path with three attempts to record the electrical activity of the muscles, in order to record the electrical activity of the muscles, so that the subjects will perform this task with 6 types of boots in the first phase of the training, then enter the phase. They are trained, and at this stage, people are asked to use the boots in their daily activities and running for at least 4 hours a day. And polyurethane and thermoplastic polyurethane boots will be repeated to check the longevity effect of the boots. Previous studies have investigated the variables of ground reaction force, electromyography activity and plantar pressure variables separately. American and British boots have paid.
Category
Diagnosis
2
Description
Control group: Each subject once without using any type of shoes with 3 attempts, once with operational boots with rubber or rubber soles with three attempts, once with polyurethane and rubber boots (double density) with three attempts and once with polyurethane boots And the thermoplastic polyurethane covers the 18-meter path with three attempts to record the electrical activity of the muscles, so that the subjects will do this task with 6 types of boots. After 14 months, these tests are repeated again.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohaghegh Ardabili university
Full name of responsible person
Milad piran hamlabadi
Street address
• No. 3, Attayee Ave., Daneshgah Blvd., kosar Town
City
Ardabil
Province
Ardabil
Postal code
56199-13131
Phone
+98 45 3150 5002
Fax
+98 45 3351 2200
Email
miladpiran75@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Jebrail Razmjoo
Street address
No. 3, Attayee Ave., Daneshgah Blvd., kosar Town
City
Ardabil
Province
Ardabil
Postal code
56199-13131
Phone
+98 45 3150 5002
Email
razmjou@uma.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University Of Mohaghegh Ardabili
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 Mohaghegh Ardabili
Full name of responsible person
DR. Amir Ali Jafarnezhad Gero
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
No. 3, Attayee Ave., Daneshgah Blvd., Kosar Town
City
Ardabil
Province
Ardabil
Postal code
56199-13131
Phone
+98 45 3150 5002
Email
Amiralijafarnezhad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University Of Mohaghegh Ardabili
Full name of responsible person
Amir Ali Jafarnezhad Gero
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
No. 3, Attayee Ave., Daneshgah Blvd., Kosar Town
City
Ardabil
Province
Ardabil
Postal code
56199-13131
Phone
+98 45 3150 5002
Email
Amiralijafarnezhad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University Of Mohaghegh Ardabili
Full name of responsible person
Milad Piran Hamlabadi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
No. 3, Attayee Ave., Daneshgah Blvd., kosar Town
City
Ardabil
Province
Ardabil
Postal code
56199-13131
Phone
+98 45 3150 5202
Email
miladpiran75@gmail.com
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
Information on ground reaction force variables and electromyography activity will be published
When the data will become available and for how long
Access starts from 2022/09/16
To whom data/document is available
Data will be provided to researchers through articles or theses
Under which criteria data/document could be used
If the distribution is normal
From where data/document is obtainable
Journals and email of the corresponding author
What processes are involved for a request to access data/document