Protocol summary

Study aim
comparing the effects of corrective-plyometric exercises with and without visual feedback on landing biomechanics and dynamic balance in female athletes with dynamic knee valgus
Design
Two arm parallel group randomised trial with single blinding, on 26 female athletes.
Settings and conduct
Both experimental groups will receive the same exercise protocol but in two different rooms in Miresmaili sport complex in Tehran city. One room in which feedback group will practice has full-mirrored walls. Exercise group will practice in another room without mirrored walls. Before each exercise, the examiner defines, and shows the correct alignment and ideal performance to the participants. In single blinding, assessor is not aware of subjects' information and their tests data are processed based on their given numbers, instead of their names.
Participants/Inclusion and exclusion criteria
Inclusion criteria: observing knee dynamic valgus by single-leg squat test and regular physical and sports activity between the last 3-5 years. Exclusion criteria: suffering from spine or lower extremity diseases, history of fracture, sprain, or strain in lower extremity, history of spine or lower extremity surgery, using any medicine or painkiller.
Intervention groups
Exercise group: They practice 30 minutes of corrective exercises and jump-landing exercises without receiving feedback for 6 weeks (3sessions each week). Feedback group: They practice 30 minutes of corrective exercises and jump-landing exercises in front of a mirror to receive visual feedback for 6 weeks (3sessions each week). Control group: They do not receive any exercises and follow their daily sports routines.
Main outcome variables
Kinematics (angles) of hip, knee, and ankle joints, Kinetics (moments and reaction forces) of hip, knee, and ankle joints,Dynamic balance in anterior, posteromedial, and posterolateral directions.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180626040244N1
Registration date: 2020-11-21, 1399/09/01
Registration timing: registered_while_recruiting

Last update: 2020-11-21, 1399/09/01
Update count: 0
Registration date
2020-11-21, 1399/09/01
Registrant information
Name
Rahman Sheikhhoseini
Name of organization / entity
Allameh Tabataba'i University
Country
Iran (Islamic Republic of)
Phone
+98 21 4839 4134
Email address
rahmanhoseini@atu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-13, 1399/07/22
Expected recruitment end date
2020-12-15, 1399/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effects of 6-week corrective-plyometric training with and without visual feedback on lower extremity Biomechanics and dynamic balance in junior female athletes with dynamic knee valgus
Public title
effects of 6-week corrective-plyometric training with and without visual feedback on dynamic knee valgus
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Observing dynamic knee valgus by performing single leg squat test Regular physical activity between 3 to 5 years
Exclusion criteria:
suffering from spine or lower extremity disorders history of fracture, sprain, or strain in lower extremity history of spine or lower extremity surgery using any medicine or painkiller
Age
From 10 years old to 14 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Investigator
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
After screening, by simple randomization participants will be divided into 3 groups of control (8 participants), exercise (8 participants), and feedback (10 participants). The randomization is going to be done by random numbers chart, by considering numbers between 0 to 8 for control group, 8 to 16 for exercise group, and 16 to 26 for feedback group. The researcher will choose one of the numbers and move through a previously determined direction and register the number and give it to the related group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the assessor (who is the researcher) is blinded to the participants' information (single blinding), and the results of participants tests are analyzed based on participants' given number and without knowing their names. That information includes participants names, and weight, height, and age information.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation Sciences
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.USWR.REC.1398.007

Health conditions studied

1

Description of health condition studied
Dynamic knee valgus
ICD-10 code
M21.06
ICD-10 code description
Valgus deformity, not elsewhere classified, knee

Primary outcomes

1

Description
lower extremity kinematics in 3 motion planes
Timepoint
before starting the interventions, and after 6 weeks of exercise interventions
Method of measurement
8 Vicon motion capture cameras, a Kistler force plate

2

Description
lower extremity kinetics in 3 motion planes
Timepoint
before starting the interventions, and after 6 weeks of exercise interventions
Method of measurement
8 Vicon motion capture cameras, a Kistler force plate

3

Description
Dynamic balance
Timepoint
before starting the interventions, and after 6 weeks of exercise interventions
Method of measurement
Y-balance kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: This group will practice 6 weeks of plyometric-exercises with visual feedback during the exercises from a mirror in a sports gym. Each week includes 3 sessions of practice which takes 30 minutes. Exercises include squats, balance training, and jump-landing exercises.
Category
Prevention

2

Description
Intervention group 2: This group will practice 6 weeks of plyometric-exercises without any visual feedback during the exercises, in a sports gym. Each week includes 3 sessions of practice which takes 30 minutes. Exercises include squats, balance training, and jump-landing exercises.
Category
Prevention

3

Description
Control group: This group will not receive any exercises from the assessor and continues their daily routine activities.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Miresmaieli sports complex
Full name of responsible person
Mahdis Dadfar
Street address
Majidiyeh park - Majidiyeh street - Shamsabad
City
Tehran
Province
Tehran
Postal code
1671843111
Phone
+98 21 2232 3265
Email
mahdisidadfar3@gmail.com
Web page address
http://ptmodares.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Dr Habib Honari
Street address
West Azadi sports complex entrance, Hakim highway
City
Tehran
Province
Tehran
Postal code
۱۴۸۵۷۴۳۴۱۱
Phone
+98 21 4473 7636
Email
international@atu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Allameh Tabataba'i 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
Allameh Tabatabai University
Full name of responsible person
Rahman Sheikh Hoseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
West Azadi sports complex entrance, Hakim highway
City
Tehran
Province
Tehran
Postal code
۱۴۸۵۷۴۳۴۱۱
Phone
+98 21 4411 8629
Email
rahmanhoseini@atu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Allameh Tabatabai University
Full name of responsible person
Rahman Sheikh Hoseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
West Azadi sports complex entrance, Hakim highway
City
Tehran
Province
Tehran
Postal code
۱۴۸۵۷۴۳۴۱۱
Phone
+98 21 4411 8629
Email
rahmanhoseini@atu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Allameh Tabatabai University
Full name of responsible person
Rahman Sheikh Hoseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
West Azadi sports complex entrance, Hakim highway
City
Tehran
Province
Tehran
Postal code
۱۴۸۵۷۴۳۴۱۱
Phone
+98 21 4411 8629
Email
rahmanhoseini@atu.ac.ir

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
After publication, the data which will be also presented in the article, will be given to the researchers in Excel format which includes the pre and post interventions' results of landing tests' biomechanical analysis and dynamic balance, for future studies like meta-analysis studies.
When the data will become available and for how long
After publication
To whom data/document is available
The published data of the current study will be accessible for the researchers in the academic institutes and universities, and also people who work in the industry.
Under which criteria data/document could be used
After publishing the article, the data will be used in future researches, like meta-analysis or other types of researches.
From where data/document is obtainable
Responding author
What processes are involved for a request to access data/document
Sending via an email
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