Effects of a Theraband exercise on muscular electrical activity in individuals with genu valgus during walking and running
Design
A clinical trial study with experimental and control groups, with parallel groups, three blind, randomized
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
People with a genu valgum. Entry requirements for having a suitable age and having a genu valgum disorder
Intervention groups
Intervention group: Genu valgum group (barefoot walking and running before after corrective exercise)
Control group: Genu valgum group (barefoot walking and running before after 8 weeks without any intervention)
Main outcome variables
Electric activity of the muscle, co-contraction and ground reaction force
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181223042082N1
Registration date:2019-02-14, 1397/11/25
Registration timing:prospective
Last update:2019-02-14, 1397/11/25
Update count:0
Registration date
2019-02-14, 1397/11/25
Registrant information
Name
Farshad Ghorbanlou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 2339
Email address
f.ghorbanlou@student.uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-07, 1398/01/18
Expected recruitment end date
2019-06-10, 1398/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of a Theraband exercise on muscular electrical activity in individuals with genu valgus during walking and running
Public title
The effect of corrective exercise on genu valgum
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Gender: Male
Having a genu valgum complication
Exclusion criteria:
History of lower limb ant trunk Injury
History of surgery
Age
No age limit
Gender
Male
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants, the main researcher and the evaluator, do not interfere in the process of data recording and analysis
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Daneshghah street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Approval date
2018-10-07, 1397/07/15
Ethics committee reference number
IR.ARUMS.REC.1397.091
Health conditions studied
1
Description of health condition studied
Genu valgum
ICD-10 code
M21.0
ICD-10 code description
Valgus declassifiedformity, not elsewhere
Primary outcomes
1
Description
Muscle co-contraction
Timepoint
8 weeks
Method of measurement
Electromyography
Secondary outcomes
1
Description
Ground reaction force
Timepoint
8 weeks
Method of measurement
Force plate system
Intervention groups
1
Description
Intervention group: Intervention group includes subjects with genu valgum who will be tested before and after 8 weeks of corrective exercise. The training program will be done 3 sessions in a week for 50 minutes.
Category
Rehabilitation
2
Description
Control group: Control group includes subjects with genu valgum who will be tested before and after 8 weeks without exercise.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Mohaghegh Ardabili
Full name of responsible person
Amirali Jafarnezhadgero
Street address
Daneshghah steet
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
University Of Mohaghegh Ardabili
Full name of responsible person
Abolfazl Bezaatpour
Street address
Daneshghah Street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5649
Email
a.bezaatpour@yahoo.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
1
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
Iranian academic center for education culture and research
Full name of responsible person
Amirali Jafarnezhadgero
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Daneshghah street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5649
Email
amiralijafarnezhad@gmail.com
Person responsible for scientific inquiries
Contact
contact.organization_id
0
Name of organization / entity
Full name of responsible person
Amirali Jafarnezhadgero
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Daneshghah 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
Anatomy
Street address
Daneshghah 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Effects of a Theraband exercise on muscular electrical activity in individuals with genu valgus during walking and running
When the data will become available and for how long