Foot; Pronation, CongenitalNCT05821803
The Effect of Exercise Training and Arch Supported Insoles on Balance and Vertical Jump Performance in Football Players With Foot Pronation Deformity
A study testing Using Insoles and Foot Core Exercises in people with Foot; Pronation, Congenital, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of foot pronation exercises and arch support insoles on balance and vertical jump test in football players. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Foot; Pronation, Congenital
- What is being tested?
- Using Insoles and Foot Core Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 May 2022to 13 Jul 2022
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntary participation in research
- To be between the ages of 18-45
- Overpronation foot ( navicular drop test over 10 mm and FootBalance device with visual display)
- Professional football players at least 5 years
Who cannot join
- History of surgery for musculoskeletal structures in both lower extremities
- History of fracture in both lower extremities
- Acute injury of the musculoskeletal structures of other joints of the lower extremity affecting joint function and integrity in the last 3 months
- Have any other knee pathology
- Balance or vestibular disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Exercise Training and Arch Supported Insoles on Balance and Vertical Jump Performance in Football Players With Foot Pronation Deformity: Randomized Controlled Trial
This study aims to investigate the effects of foot pronation exercises and arch support insoles on balance and vertical jump test in football players.
Read the detailed description
The study took place in FootBalance Turkey, which works on foot analysis and insoles.
30 professional football players with pronation who divided into two groups. The football players in the Experimental Group used insoles and also participated the foot core exercise program twice a week for 4 weeks duration. The football players in the Control Group just used the insoles.We used the FootBalance assessmnet system for insoles. Navicular Drop Test, Y Balance Test, Flamingo Testand Vertical Jump Test applied to evalute foot pronation, dynamic balance, static balance and jump performace respectively.
- Conditions
- Foot; Pronation, Congenital
- Being tested
- Using Insoles, Foot Core Exercises
- Keywords
- Foot pronation, Insoles, Footcore exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using InsolesOther
FootBalance %100 Control Orthopedic insoles used for 4 weeks.
Foot Core ExercisesOther
4 weeks including
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Insoles
Foot Core Exercises Receives: Other: Using Insoles; Other: Foot Core Exercises |
| Control Group | Active comparator | Insoles Receives: Other: Using Insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Navicular Drop Test
It is the one of the static foot assessment tool and is intended to represent the sagittal plane displacement of the navicular tuberosity from a neutral position.
Measured: 4 weeks
Y Balance Test/ Dynamic Balance Evaluation
The Star Excursion Balance Test (SEBT) is a dynamic test that requires strength, flexibility, and proprioception. It is a measure of dynamic balance that provides a significant challenge to athletes and physically active individuals.
Measured: 4 weeks
Flamingo Balance Test/ Static Balance Evalutaion
The flamingo balance test is a total body balance test in order to test static balance.
Measured: 4 weeks
Vertical Jump Test
Vertical jump test to determine an athlete's physical ability. The vertical jump as a test of lower body explosive power
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start13 May 2022
- Primary completion1 Jul 2022
- Study completion13 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot; Pronation, CongenitalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Collaborators
- FootBalance
- Responsible party
- Principal investigator, Gizem Karadeniz, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821803
- Sponsor's protocol ID
- GizemK
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise Training and Arch Supported Insoles on Balance and Vertical Jump Performance in Football Players With Foot Pronation Deformity: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05821803
- Acronym / sponsor ID
- GizemK
- Conditions
- Foot; Pronation, Congenital
- Keywords
- Foot pronation, Insoles, Footcore exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Collaborators
- FootBalance
- Study start
- 13 May 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 20 Apr 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.
This study aims to investigate the effects of foot pronation exercises and arch support insoles on balance and vertical jump test in football players.
Detailed description
The study took place in FootBalance Turkey, which works on foot analysis and insoles.
30 professional football players with pronation who divided into two groups. The football players in the Experimental Group used insoles and also participated the foot core exercise program twice a week for 4 weeks duration. The football players in the Control Group just used the insoles.We used the FootBalance assessmnet system for insoles. Navicular Drop Test, Y Balance Test, Flamingo Testand Vertical Jump Test applied to evalute foot pronation, dynamic balance, static balance and jump performace respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Using Insoles, Other: Foot Core ExercisesInsoles Foot Core Exercises |
| Control Group | Active comparator | Other: Using InsolesInsoles |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Voluntary participation in research
- To be between the ages of 18-45
- Overpronation foot ( navicular drop test over 10 mm and FootBalance device with visual display)
- Professional football players at least 5 years
Key exclusion criteria (5 listed)
- History of surgery for musculoskeletal structures in both lower extremities
- History of fracture in both lower extremities
- Acute injury of the musculoskeletal structures of other joints of the lower extremity affecting joint function and integrity in the last 3 months
- Have any other knee pathology
- Balance or vestibular disorder
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 |
|---|---|---|
| Using InsolesFootBalance %100 Control Orthopedic insoles used for 4 weeks. | Other | Control Group, Experimental Group |
| Foot Core Exercises4 weeks including | Other | Experimental Group |
Primary outcome
Navicular Drop Test
Time frame: 4 weeks
It is the one of the static foot assessment tool and is intended to represent the sagittal plane displacement of the navicular tuberosity from a neutral position.
Y Balance Test/ Dynamic Balance Evaluation
Time frame: 4 weeks
The Star Excursion Balance Test (SEBT) is a dynamic test that requires strength, flexibility, and proprioception. It is a measure of dynamic balance that provides a significant challenge to athletes and physically active individuals.
Flamingo Balance Test/ Static Balance Evalutaion
Time frame: 4 weeks
The flamingo balance test is a total body balance test in order to test static balance.
Vertical Jump Test
Time frame: 4 weeks
Vertical jump test to determine an athlete's physical ability. The vertical jump as a test of lower body explosive power
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 20 Apr 2023.
Related trials for Foot; Pronation, Congenital
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Patellofemoral Joint, Flatfoot
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using Insoles and Foot Core Exercises in people with Foot; Pronation, Congenital, run by Yeditepe 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 4 inclusion and 5 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 20 Apr 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?
Navicular Drop Test (time frame: 4 weeks). 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?
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 20 Apr 2023.