Protocol summary

Study aim
Comparisons of gait biomechanics in ACL reconstructed subjects with and without foot pronation
Design
Thirty male subjects will be volunteered to participate in this study. They will be divided in three groups (1- healthy controls; 2- ACL reconstructed subjects with normal feet; 3- ACL reconstructed subjects with foot pronation ).
Settings and conduct
Gait analysis will be done by motion capture systems in biomechanics laboratory in Islamic Azad University, Hamedan, Iran.
Participants/Inclusion and exclusion criteria
The subjects must have ACL reconstructed ligament
Intervention groups
1- Healthy subjects 2- ACL reconstructed subjects with normal feet 3- ACL reconstructed subjects with foot pronation
Main outcome variables
1- Kinematic variables 2- Kinetic variables

General information

Reason for update
Acronym
Gait
IRCT registration information
IRCT registration number: IRCT20180522039781N1
Registration date: 2018-06-03, 1397/03/13
Registration timing: prospective

Last update: 2018-06-03, 1397/03/13
Update count: 0
Registration date
2018-06-03, 1397/03/13
Registrant information
Name
Morteza Madadi-Shad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3831 6081
Email address
m.madadishad@basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The immediate effect of anti-pronation foot orthoses on kinematic and kinetics of gait in ACL reconstructed individuals with and without pronated feet
Public title
The gait analysis of ACL reconstructed individuals
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ACL injury of the subjects
Exclusion criteria:
ُSymptoms of pain, fatigue, and physical limitations in the subjects ُSigns of joints diseases,diseases of bones and neuromuscular dysfunction in the subjects
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Hamedan University of Medical Sciences
Street address
Ahmadi-roshan Ave., Hamedan., Iran
City
Hamedan
Province
Hamadan
Postal code
6515846549
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
IR.UMSHA.REC1397.118

Health conditions studied

1

Description of health condition studied
The subjects one year post ACL reconstruction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The kinematics and kinetics of lower limb joints during walking
Timepoint
cross-sectional study
Method of measurement
1- Motion control device (3 dimensional camera), 2- Force platform

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: before and after using an anti-pronation foot orthoses (medial arch support insole), the biomechanical analysis of walking in ACL reconstructed individuals with pronated feet (flat feet) will be done by using three-dimensional camera in laboratory.
Category
Treatment - Other

2

Description
Intervention group: before and after using an anti-pronation foot orthoses (medial arch support insole), the biomechanical analysis of walking in ACL reconstructed individuals with normal foot type will be done by using three-dimensional camera in laboratory.
Category
Treatment - Other

3

Description
Control group: before and after using an anti-pronation foot orthoses (medial arch support insole), the biomechanical analysis of walking in normal healthy individuals will be done by using three-dimensional camera in laboratory.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Morteza Madadi Shad
Street address
Shahid Beheshti Ave., Hamedan., Iran
City
Hamedan
Province
Hamadan
Postal code
6515973982
Phone
+98 81 3264 0030
Email
Besat@umsha.ac.ir
Web page address
http://besat.umsha.ac.ir/index.aspx?siteid=49&pageid=3328

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
علی یلفانی
Street address
Shahid Ahmadi-roshan Ave., Hamedan., Iran
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1601
Email
buali@basu.ac.ir
Web page address
https://www.basu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Bu-Ali Sina 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
Bu Ali Sinal University
Full name of responsible person
Nader Farahpour
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Biomechanics
Street address
Shahid Ahmadi-roshan Ave., Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1601
Email
mortezamadadishad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Nader Farahpour
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Biomechanics
Street address
Shahid Ahmadi-roshan Ave., Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1601
Email
mortezamadadishad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Morteza Madadi Shad
Position
Student
Latest degree
Master
Other areas of specialty/work
Biomechanics
Street address
Shahid Ahmadi-roshan Ave., Hameedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1601
Email
mortezamadadishad@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
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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