IRCT | The effect of combining of the German Knee Association training program (STOP X) and ankle mobility exercises on lower limb kinematics, landing error, balance and proprioception of adolescent soccer players with dynamic knee valgus.

Protocol summary

Study aim: The purpose of the present study was to investigate the effect of combining of the German Knee Association training program (STOP X) and ankle mobility exercises on lower limb kinematics, landing error, balance and proprioception of adolescent soccer players with dynamic knee valgus.
Design: Clinical trial with control group, with parallel groups, single blinded, randomized
Settings and conduct: The field tests include: single-leg landing test to evaluate knee dynamic valgus, Y balance test to measure dynamic balance, and LESS test will be used to evaluate knee position during landing. A goniometer will also be used to evaluate the knee joint's proprioceptive function.The tests will take place in the sports hall and then the intervention and training will take place in the takhti football stadium.
Participants/Inclusion and exclusion criteria: Inclusion criteria included; Adolescent soccer players with knee dynamic valgus, having at least three training sessions per week, no having any history of back pain or knee and ankle injuries, and exclusion criteria; ligament damage in the ankle and knee, history of surgery in the lower limb, the absence of more than two sessions of the subjects in the exercises.
Intervention groups: STOP X training group, STOP X training combination group and ankle mobility
Main outcome variables: ACL tear of the knee

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20221215056826N2

Registration date: 2023-03-04, 1401/12/13

Registration timing: registered_while_recruiting

Last update: 2023-03-04, 1401/12/13

Update count: 0
Registration date: 2023-03-04, 1401/12/13

Registrant information: Name

Yasaman Ghadiri

Name of organization / entity

Boali Sina University

Country

Iran (Islamic Republic of)

Phone

+98 81 3838 1423

Email address

y.ghadiri@phe.basu.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-03-03, 1401/12/12
Expected recruitment end date: 2023-03-13, 1401/12/22
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effect of combining of the German Knee Association training program (STOP X) and ankle mobility exercises on lower limb kinematics, landing error, balance and proprioception of adolescent soccer players with dynamic knee valgus.

Public title: The effect of combining two separate training protocols on reducing the dynamic knee valgus angle in adolescent soccer players
Purpose: Prevention
Inclusion/Exclusion criteria: Inclusion criteria:

Adolescent soccer players with dynamic knee valgus Not having history of back pain, knee and ankle injuries Having at least three training sessions per week

Exclusion criteria:

Having Ligament damage in the ankle and knee History of lower limb surgery Absence of more than two seasons of subjects in the exercise
Age: From 12 years old to 15 years old
Gender: Male

Phase

N/A

Groups that have been masked

Participant

Sample size

Target sample size: 30

Randomization (investigator's opinion)

Randomized

Randomization description

Randomization is done based on the Random Number Generator software, and they will be assigned to double groups based on the allocation concealment using the SNOSE method. The randomization of subjects is done in two stages. First, each of the subjects chooses a number between 1-30 using a lottery, then using the Random number generator software, fifteen random numbers are selected between the numbers 1-30, and according to the generated numbers and the selected numbers, the subjects are divided into two groups.

Blinding (investigator's opinion)

Single blinded

Blinding description

These people will be unaware of the purpose of the research, the allocation of study groups and the reason for their presence in the laboratory. And they only evaluate the variables and record their observations. The blinding of the participants will be done in such a way that each group will do their own exercises and in order to achieve the blinding, the members of the two groups will be present in the hall to receive the exercises on two different days.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Bu Ali Sina University

Street address

Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan

City

Hamedan

Province

Hamadan

Postal code

3869565178
Approval date: 2022-03-08, 1400/12/17
Ethics committee reference number: IR.BASU.REC.1401.023

Health conditions studied

1

Description of health condition studied: Dynamic knee valgus of adolescent football player
ICD-10 code: S83.5
ICD-10 code description: Sprain of cruciate ligament of knee

Primary outcomes

1

Description: Dynamic knee valgus
Timepoint: Before the intervention begins, one day after the end of the intervention
Method of measurement: Single leg test

2

Description: Landing eror
Timepoint: Before the intervention begins, one day after the end of the intervention
Method of measurement: Less test

3

Description: Y balance
Timepoint: Before the intervention begins, one day after the end of the intervention
Method of measurement: Y balance test

4

Description: Proprioception
Timepoint: Before the intervention begins, one day after the end of the intervention
Method of measurement: Goniometer

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group one: STOP X training, STOP X exercise for 8 weeks and 3 sessions of 1 hour each week. The STOP X protocol includes balance, strength, and jumping exercises designed by the German Knee Association.
Category: Prevention

2

Description: Intervention group two: The combination of STOP X and ankle mobility exercises will be for 8 weeks and 3 sessions of 1 hour each week. The ankle training protocol includes releasing the plantar flexors by wooden roller massager and stretching these muscles in different positions.
Category: Prevention

Recruitment centers

1

Recruitment center: Name of recruitment center

Ghorveh City General Administration of sport

Full name of responsible person

Majid Ghanbari

Street address

Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan

City

Hamedan

Province

Hamadan

Postal code

3869565178

Phone

+98 81 3838 1423

Email

M.ghanbari@phe.basu.ac.ir

1

Sponsor: Name of organization / entity

Bu Ali Sina University

Full name of responsible person

Farzane Saki

Street address

Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan

City

Hamedan

Province

Hamadan

Postal code

3869565178

Phone

+98 81 3838 1423

Email

f.sport2008@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
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 Sina University

Full name of responsible person

Majid Ghanbari

Position

Student

Latest degree

Bachelor

Other areas of specialty/work

Sport Rehabilitation

Street address

Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan

City

Hamedan

Province

Hamadan

Postal code

3869565178

Phone

+98 81 3838 1423

Email

M.ghanbari@phe.basu.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Bu Ali Sina University

Full name of responsible person

Majid Ghanbari

Position

Student

Latest degree

Bachelor

Other areas of specialty/work

Sport Rehabilitation

Street address

Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan

City

Hamedan

Province

Hamadan

Postal code

3869565178

Phone

+98 81 3838 1423

Email

M.Ghanbari@phe.basu.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Bu Ali Sina University

Full name of responsible person

Majid Ghanbari

Position

Student

Latest degree

Bachelor

Other areas of specialty/work

Sport Rehabilitation

Street address

Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan

City

Hamedan

Province

Hamadan

Postal code

3869565178

Phone

+98 81 3838 1423

Email

M.ghanbari@phe.basu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

The effect of combining of the German Knee Association training program (STOP X) and ankle mobility exercises on lower limb kinematics, landing error, balance and proprioception of adolescent soccer players with dynamic knee valgus.