The Effect of Using Medial Longitudinal Arch Supported Insoles on Jumping in Young Football Players

December 6, 2023 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
In this study, it was aimed to determine the effect of pressing styles and insoles on jumping performances.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this clinical study, 30 healthy male football players between the ages of 16-20 will be carried out at Kasımpaşa Sports Club Academy. In the study, the effect of medial longitudinal arch height and the use of insoles on jumping using vertical jump, countermovement jump and drop jump tests will be investigated. Football players; Medial longitudinal arch heights will be measured by applying Foot Posture Index-6 and Navicular Position Test. As a result of these measurements; flat sole, normal sole and high sole will be divided into three groups. These three groups; Vertical jumping, countermovement jumping and drop jumping tests will be applied with the help of portable jumping apparatus and the results will be recorded. These tests will be re-applied to all three groups with a non-personalized, prefabricated insole that supports the medial arch. According to these tests, it will be investigated whether jumping performance depends on medial arch height. It will be evaluated whether there is a change in jumps after the insoles used. The obtained data will be analyzed statistically.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Kasimpasa Sports Club

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Football players between the ages of 16-20 will be included in the study.
  • Football players who were not injured at the time of the study were included in the study will be.
  • Football players who allow and want to participate in the study will be included in the study.

Exclusion Criteria:

• Football players who had an injury at the time of the study were included in the study will not be.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: flat sole
Weighted-unweighted in navicular drop test 10 mm or more pronation
Device: insoles
Insoles are support devices that take the shape of the foot structure and enable the foot to press in a correct form.
Experimental: normal base
Weighted-unweighted in navicular drop test difference between measurement 5-9 mm is normal
Device: insoles
Insoles are support devices that take the shape of the foot structure and enable the foot to press in a correct form.
Experimental: high sole
Weighted-unweighted in navicular drop test 4 mm or less is considered supination. are being
Device: insoles
Insoles are support devices that take the shape of the foot structure and enable the foot to press in a correct form.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vertical jump test
Time Frame: 1 day
It is a test used to determine the jump height in athletes. In our study; The jump starting position for this test will be with the knees flexed at 90 degrees, the head facing forward, the arms positioned freely at the side of the body. While jumping; Upward jumping will be required with a sudden thrust. During this jump, the ankle will be plantar flexed, the knees and hips extended, and the arms will be lifted upwards. During landing, the ankle will contact the ground with dorsiflexion, knees and hips extended, and return to the starting position. 3 repetitions will be done and the highest will be accepted.
1 day
Countermovement Jump Test
Time Frame: 1 day
It is a frequently used method to evaluate the capacity of the musculoskeletal system in athletes. It is generally used to monitor the training capacity of athletes through parameters such as jump height, strength, power and speed. The jump start position for this test will be positioned with the knees flexed at 90 degrees, the head facing forward, with the hands on the waist from the sides to restrict the movement of the arms. While jumping; Upward jumping will be required with a sudden thrust. During this jump, the ankle will be plantar flexed, the knees and hips will be extended, and the hands will be at the waist. During landing, the ankle will contact the ground with dorsiflexion, knees and hips extended, and return to the starting position. 3 repetitions will be done and the highest will be accepted.
1 day
Drop Jump Test
Time Frame: 1 day
In our study, the starting position for this test will be on a high jump box with the hands at the sides on the waist and in a standing upright position. To initiate the fall movement, participants will be instructed: "step out of the box with one foot and try to make the highest jump immediately after contact with the ground". The player will be instructed not to leave the jumping platform and jump out of the box for landing and jumping. The jump box will be 30 cm high. 3 repetitions will be done and the highest will be accepted. Reliability tests were conducted for jumping tests.
1 day
Navicular position test
Time Frame: 1 day
The test is done standing up. For whichever foot it will be applied, that foot will be in the back, the other foot will be in front, and the calcaneus of the front foot and the tip of the toe of the back foot will be on the same horizontal plane. In the extremity to be applied, the knee will be kept in a bent position so that it is vertically aligned with the 1st and 2nd finger. In this position, mark the head of the 1st metatarsal bone, the navicular bone, the apex of the medial malleolus, and the dorsal of the Achilles tendon horizontally aligned. First, a line is drawn and extended between the head of the 1st metatarsal bone and the navicular bone. Second, a line is drawn and lengthened between the navicular bone and the Achilles tendon. The angle between these two lines is measured.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uskudar University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ahmet Can GÜNGÖRDÜ, Kasimpasa Sports Club

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Uskudar52

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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