Comparison of the influence of new and worn sport shoes on muscular co-contraction and plantar pressure variables during running in individuals with genu varus
Evaluation the influence of sport shoe ageing on muscular co-contraction and plantar pressure variables in individuals with genu varus during running
Design
Triple blind clinical trial with experimental, control and parallel group.
Settings and conduct
This study will be done at Mohaghegh Ardabili University. Present study is a triple blind one. Participants, main researcher and outcome assessor will not aware of the grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individuals with genu varus; age range between 18 to 35 years old.
Non-inclusion criteria: history of lower limb and trunk injuries; history of surgery.
Intervention groups
Intervention group: Genu varus group (running with both new and worn sport shoes in subjects with genu varus). Control group: Healthy group (running with both new and worn sport shoes in healthy subjects).
Main outcome variables
Muscle co-contraction, Ground reaction forces
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170806035517N3
Registration date:2019-01-25, 1397/11/05
Registration timing:registered_while_recruiting
Last update:2019-01-25, 1397/11/05
Update count:0
Registration date
2019-01-25, 1397/11/05
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
2018-12-21, 1397/09/30
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the influence of new and worn sport shoes on muscular co-contraction and plantar pressure variables during running in individuals with genu varus
Public title
Effect of shoe aging on biomechanical variables
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with genu varus
Age range between 18-35 years old
Exclusion criteria:
History of lower limb and trunk injuries
History of surgery
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
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)
Triple blinded
Blinding description
Participants, main researcher, and output evaluator will kept blind in this study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical comitee of Ardabil University of Medical Sciences
Street address
Daneshgah street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Approval date
2018-11-19, 1397/08/28
Ethics committee reference number
IR.ARUMS.REC.1397.135
Health conditions studied
1
Description of health condition studied
Genu varus
ICD-10 code
M21.1
ICD-10 code description
Varus deformity, not elsewhere classified
Primary outcomes
1
Description
Muscles co-contraction
Timepoint
Before and after 6 months
Method of measurement
Electromyography and force plate systems
Secondary outcomes
1
Description
Ground reaction forces
Timepoint
Before and after 6 months
Method of measurement
Forceplate system
Intervention groups
1
Description
Intervention group: Intervention group include subjects with genu varus who will be tested by wearing new and worn sport shoes. The brand of shoes will be Adidas- climaCool. During intervention period (6 months), the subjects will wear this shoe as maximum as possible during their daily activities.
Category
Diagnosis
2
Description
Control group: Control group includes healthy subjects who will be tested by wearing new and worn sport shoes. The brand of shoes will be Adidas- climaCool. During intervention period (6 months), the subjects will wear this shoe as maximum as possible during their daily activities.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohaghegh Ardabili University
Full name of responsible person
AmirAli Jafarnezhadgero
Street address
Danshgah street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5649
Email
amiralijafarnezhad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
AmirAli Jafarnezhadgero
Street address
Danshgah street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5649
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
Ardabil University of Medical Sciences
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
Ardabil University of Medical Sciences
Full name of responsible person
AmirAli Jafarnezhadgero
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Ergonomics
Street address
Danshgah street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5649
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
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Ergonomics
Street address
Danshgah street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5649
Email
amiralijafarnezhad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
AmirAli Jafarnezhadgero
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Ergonomics
Street address
Danshgah street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5649
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
Raw data and SPSS file
When the data will become available and for how long
After the end of the study
To whom data/document is available
All people
Under which criteria data/document could be used
After publication of manuscripts
From where data/document is obtainable
AmirAli Jafarnezhadgero
What processes are involved for a request to access data/document