Protocol summary

Study aim
Evaluation the Effects of Using Insoles with Different Densities in Military Boots on Ground Reaction Forces and Lower Limb Muscular Activities During Walking and Running
Design
The statistical sample of the current study will include 20 healthy military personnel and 20 military personnel with navicular bone loss with an age range of 25-30 years.
Settings and conduct
This research is a semi-experimental type, which will be conducted in the form of pre-test and post-test in the sports biomechanics laboratory of Mohaghegh Ardabili University.
Participants/Inclusion and exclusion criteria
1- The subjects will be healthy military men. 2- Subjects should not have any history of ankle sprain in the past year. 3- All subjects should have complete knowledge about walking and running.
Intervention groups
Both the experimental (pronation foot) and healthy groups will use insoles
Main outcome variables
Ground reaction forces and electrical activity of lower limb muscles

General information

Reason for update
Acronym
FO
IRCT registration information
IRCT registration number: IRCT20220129053865N1
Registration date: 2024-08-19, 1403/05/29
Registration timing: prospective

Last update: 2024-08-19, 1403/05/29
Update count: 0
Registration date
2024-08-19, 1403/05/29
Registrant information
Name
Ebrahim Piri
Name of organization / entity
Mohaghegh Ardabili University
Country
Iran (Islamic Republic of)
Phone
+98 914 538 4056
Email address
ebrahimm.piri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-18, 1403/06/28
Expected recruitment end date
2024-10-19, 1403/07/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Effects of Using Insoles with Different Densities in Military Boots on Ground Reaction Forces and Lower Limb Muscular Activities During Walking and Running
Public title
Evaluation the Effects of Using Insoles with Different Densities in Military Boots on Ground Reaction Forces and Lower Limb Muscular Activities During Walking and Running
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects will be healthy military men. Subjects should not have any history of ankle sprain in the past year. All subjects should have complete knowledge about walking and running
Exclusion criteria:
A history of fracture surgery Neuromuscular problems
Age
From 18 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding will be done in such a way that the examiners and the examinee were not present during the test (the expert who will collect the data), so that there is no bias on the part of the subjects and the laboratory manager.
Placebo
Not used
Assignment
Other
Other design features
This research is a semi-experimental type, which will be conducted in the form of pre-test and post-test in the sports biomechanics laboratory of Mohaghegh Ardabili University.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Reserch Ethics Committees BaqiyatAllah Hospital
Street address
Ardabil
City
Ardabil
Province
Ardabil
Postal code
5638157394
Approval date
2024-06-29, 1403/04/09
Ethics committee reference number
IR.BMSU.BAQ.REC.1403.066

Health conditions studied

1

Description of health condition studied
Pronation feet
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
round Reaction Forces and Lower Limb Muscular Activities
Timepoint
Immediate effect
Method of measurement
To record the ground reaction forces during walking and running (in control and experimental conditions), using the Bertec force plate (Bertec Corporation, Columbus, OH) made in the USA with dimensions of 60 x 40 cm in three vertical, anterior-posterior and internal directions. will be used externally. The sampling rate in the Paginero device will be 1000 data per second. Ground reaction force data will be extracted during the leaning phase of walking, mid-stance and pushing phase. Butterworth filter with 20 Hz frequency cutoff will be used to filter ground reaction force data.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Pronation foot
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Sports biomechanics laboratory
Full name of responsible person
Ebrahim Piri
Street address
Ardabil
City
Ardabil
Province
Ardabil
Postal code
5638157394
Phone
+98 914 538 4056
Email
ebrahimm.piri@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ebrahim Piri
Street address
Ardabil
City
Ardabil
Province
Ardabil
Postal code
5638157394
Phone
+98 914 538 4056
Email
ebrahimm.piri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
NO
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ebrahim Piri
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Ardabli
City
Ardabli
Province
Ardabil
Postal code
5638157394
Phone
+98 45 3391 8306
Email
ebrahimm.piri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ebrahim Piri
Position
ph.d
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Ardabil
City
Ardabil
Province
Ardabil
Postal code
5638157394
Phone
+98 45 3391 8306
Email
ebrahimm.piri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ebrahim Piri
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Ardabil, University Ave, University of mohaghegh ardabili
City
Ardabil
Province
Ardabil
Postal code
5638157394
Phone
+98 45 3391 8306
Email
ebrahimm.piri@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It will only be presented in the article
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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