The effect of motion control shoes on lower limb joints kinetics in runners with pronated foot during running before and after fatigue
Design
A clinical trial Without control group, Non-randomized
Settings and conduct
The research experiments will be done in biomechanics laboratory of the University of Mazandaran, This study has double blind design (Including participants and researchers).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Runners with pronated foot
Exclusion criteria: Lack of injury or surgery history
Intervention groups
Using motion control shoes
Main outcome variables
Joint kinetics
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170806035517N2
Registration date:2018-06-08, 1397/03/18
Registration timing:retrospective
Last update:2018-06-08, 1397/03/18
Update count:0
Registration date
2018-06-08, 1397/03/18
Registrant information
Name
AmirAli Jafarnezhadgero
Name of organization / entity
University of Mohaghegh Ardabili
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 0903
Email address
a.jafarnezhad@uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-05, 1397/01/16
Expected recruitment end date
2018-04-09, 1397/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of motion control shoes on lower limb joints kinetics in runners with pronated foot during running before and after fatigue
Public title
Effect of motion control shoes on in runners with pronated foot
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Runner
pronated foot
Exclusion criteria:
History of injury
history of surgery
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
University street
City
Ardabil
Province
Ardabil
Postal code
85991-56189
Approval date
2017-11-04, 1396/08/13
Ethics committee reference number
IR.ARUMS.REC.1396.135
Health conditions studied
1
Description of health condition studied
Flat foot
ICD-10 code
M21.4
ICD-10 code description
Flat foot [pes planus] (acquired)
Primary outcomes
1
Description
Joints kinematic
Timepoint
Before and after fatigue protocol
Method of measurement
By using of motion analysis system and forceplatforms
Secondary outcomes
1
Description
Height of medial arch of the foot
Timepoint
Before and after fatigue protocol
Method of measurement
ruler
Intervention groups
1
Description
motion control shoes
Category
Treatment - Devices
2
Description
Intervention group: Control shoes
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Babolsar city
Full name of responsible person
AmirAli Jafarnezhadgero
Street address
University street
City
Ardabil
Province
Ardabil
Postal code
85991-56189
Phone
+98 51 3477 3387
Email
amiralijafarnezhad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
AmirAli Jafarnezhadgero
Street address
University street
City
Ardabil
Province
Ardabil
Postal code
85991-56189
Phone
+98 51 3477 3387
Email
amiralijafarnezhad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
University of Mohaghegh Ardabili
Full name of responsible person
AmirAli Jafarnezhadgero
Position
University master
Latest degree
Ph.D.
Other areas of specialty/work
Sport Biomechanics
Street address
University street
City
Ardabil
Province
Ardabil
Postal code
85991-56189
Phone
+98 51 3477 3387
Email
amiralijafarnezhad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
AmirAli Jafarnezhadgero
Position
University master
Latest degree
Ph.D.
Other areas of specialty/work
Sport Biomechanics
Street address
University street
City
Ardabil
Province
Ardabil
Postal code
56199-11367
Phone
+98 51 3477 3387
Email
amiralijafarnezhad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
AmirAli Jafarnezhadgero
Position
University of Mohaghegh Ardabili
Latest degree
Ph.D.
Other areas of specialty/work
Sport Biomechanics
Street address
University street
City
Ardabil
Province
Ardabil
Postal code
85991-56189
Phone
+98 51 3477 3387
Email
amiralijafarnezhad@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
By e-mail
When the data will become available and for how long
Until one year after data collection
To whom data/document is available
All people
Under which criteria data/document could be used
After manuscripts publication
From where data/document is obtainable
AmirAli Jafarnezhadgero
What processes are involved for a request to access data/document