Pes PlanusNCT06010420
The Effect of Using Medial Longitudinal Arch Supported Insoles on Jumping in Young Football Players
A study testing insoles in people with Pes Planus and Sports Physical Therapy, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to determine the effect of pressing styles and insoles on jumping performances. Read more about this study
- Who is it for?
- Ages 16 to 20 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pes Planus, Sports Physical Therapy
- What is being tested?
- insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 5 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 20 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Football players who had an injury at the time of the study were included in the study will not be.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, it was aimed to determine the effect of pressing styles and insoles on jumping performances.
Read the 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.
- Conditions
- Pes Planus, Sports Physical Therapy
- Being tested
- insoles
- Keywords
- jumping, insoles, footballer
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insolesDevice
Insoles are support devices that take the shape of the foot structure and enable the foot to press in a correct form.
| Study group | Role | What they receive |
|---|---|---|
| flat sole | Experimental | Weighted-unweighted in navicular drop test 10 mm or more pronation Receives: Device: insoles |
| normal base | Experimental | Weighted-unweighted in navicular drop test difference between measurement 5-9 mm is normal Receives: Device: insoles |
| high sole | Experimental | Weighted-unweighted in navicular drop test 4 mm or less is considered supination. are being Receives: Device: insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical jump test
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.
Measured: 1 day
Countermovement Jump Test
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.
Measured: 1 day
Drop Jump Test
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.
Measured: 1 day
Navicular position test
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Sep 2023
- Primary completion15 Oct 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pes PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- use of insoles
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
- Investigators
- Ahmet Can GÜNGÖRDÜ, Study chair, Kasimpasa Sports Club
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010420
- Sponsor's protocol ID
- Uskudar52
- Status last verified
- Dec 2023
- First submitted
- 18 Aug 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brocherie F, Millet GP, Girard O. Neuro-mechanical and metabolic adjustments to the repeated anaerobic sprint test in professional football players. Eur J Appl Physiol. 2015 May;115(5):891-903. doi: 10.1007/s00421-014-3070-z. Epub 2014 Dec 7.
PubMed 25481506Madeleine P, Hoej BP, Fernandez-de-Las-Penas C, Rathleff MS, Kaalund S. Pressure pain sensitivity changes after use of shock-absorbing insoles among young soccer players training on artificial turf: a randomized controlled trial. J Orthop Sports Phys Ther. 2014 Aug;44(8):587-94. doi: 10.2519/jospt.2014.5117. Epub 2014 Jul 16.
PubMed 25029914Girard O, Millet GP, Thomson A, Brocherie F. Is Plantar Loading Altered During Repeated Sprints on Artificial Turf in International Football Players? J Sports Sci Med. 2018 Aug 14;17(3):359-365. eCollection 2018 Sep.
PubMed 30116108Arundale AJH, Kvist J, Hagglund M, Faltstrom A. Jump performance in male and female football players. Knee Surg Sports Traumatol Arthrosc. 2020 Feb;28(2):606-613. doi: 10.1007/s00167-019-05747-1. Epub 2019 Oct 30.
PubMed 31667569Loturco I, Jeffreys I, Abad CCC, Kobal R, Zanetti V, Pereira LA, Nimphius S. Change-of-direction, speed and jump performance in soccer players: a comparison across different age-categories. J Sports Sci. 2020 Jun-Jun;38(11-12):1279-1285. doi: 10.1080/02640414.2019.1574276. Epub 2019 Feb 6.
PubMed 30724662
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Medial Longitudinal Arch Supported Insoles on Jumping in Young Football Players
- ClinicalTrials.gov ID
- NCT06010420
- Acronym / sponsor ID
- Uskudar52
- Conditions
- Pes Planus, Sports Physical Therapy
- Keywords
- jumping, insoles, footballer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, it was aimed to determine the effect of pressing styles and insoles on jumping performances.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- use of insoles
| Arm | Type | Receives |
|---|---|---|
| flat sole | Experimental | Device: insolesWeighted-unweighted in navicular drop test 10 mm or more pronation |
| normal base | Experimental | Device: insolesWeighted-unweighted in navicular drop test difference between measurement 5-9 mm is normal |
| high sole | Experimental | Device: insolesWeighted-unweighted in navicular drop test 4 mm or less is considered supination. are being |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Football players who had an injury at the time of the study were included in the study will not be.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insolesInsoles are support devices that take the shape of the foot structure and enable the foot to press in a correct form. | Device | flat sole, high sole, normal base |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Background: PubMed 25481506Brocherie F, Millet GP, Girard O. Neuro-mechanical and metabolic adjustments to the repeated anaerobic sprint test in professional football players. Eur J Appl Physiol. 2015 May;115(5):891-903. doi: 10.1007/s00421-014-3070-z. Epub 2014 Dec 7.
- Background: PubMed 25029914Madeleine P, Hoej BP, Fernandez-de-Las-Penas C, Rathleff MS, Kaalund S. Pressure pain sensitivity changes after use of shock-absorbing insoles among young soccer players training on artificial turf: a randomized controlled trial. J Orthop Sports Phys Ther. 2014 Aug;44(8):587-94. doi: 10.2519/jospt.2014.5117. Epub 2014 Jul 16.
- Background: PubMed 30116108Girard O, Millet GP, Thomson A, Brocherie F. Is Plantar Loading Altered During Repeated Sprints on Artificial Turf in International Football Players? J Sports Sci Med. 2018 Aug 14;17(3):359-365. eCollection 2018 Sep.
- Background: PubMed 31667569Arundale AJH, Kvist J, Hagglund M, Faltstrom A. Jump performance in male and female football players. Knee Surg Sports Traumatol Arthrosc. 2020 Feb;28(2):606-613. doi: 10.1007/s00167-019-05747-1. Epub 2019 Oct 30.
- Background: PubMed 30724662Loturco I, Jeffreys I, Abad CCC, Kobal R, Zanetti V, Pereira LA, Nimphius S. Change-of-direction, speed and jump performance in soccer players: a comparison across different age-categories. J Sports Sci. 2020 Jun-Jun;38(11-12):1279-1285. doi: 10.1080/02640414.2019.1574276. Epub 2019 Feb 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Can GÜNGÖRDÜ study chair
Kasimpasa Sports Club
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insoles in people with Pes Planus and Sports Physical Therapy, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical jump test (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06010420, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.