Pes PlanusNCT06251804
Effectiveness of Short-Foot Exercises in Water and on Land in Pes Planus
A study testing Water exercise program and Land-based-program in people with Pes Planus, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Pes planus is caused by the elongation of the intrinsic muscles in the medial arch of the foot, causing the arch to approach the ground or the sole of the foot to touch the ground completely. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Pes Planus
- What is being tested?
- Water exercise program and Land-based-program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2024to 10 Jul 2024
- 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 18-25
- Having bilateral pes planus
- People with a score of 6 and above on the Foot Posture Index Score
- Individuals with more than 10 millimeters of pronation according to the navicular drop test were included.
Who cannot join
- Rigid pes planus, hallux valgus, hallux rigidus, epin calcanei
- Lower extremity surgery
- Neurological or orthopedic problems and history of disease
- Regular exercise for the treatment of pes planus in the last three months
Trial locations and contacts
1 site in 1 country.
Mustafa Emre Kıyık contact
About this study
Pes planus is caused by the elongation of the intrinsic muscles in the medial arch of the foot, causing the arch to approach the ground or the sole of the foot to touch the ground completely.
Read the detailed description
For this purpose, in this project, the effectiveness of short foot exercises in water and on land will be compared in young adults with pes planus.
- Conditions
- Pes Planus
- Being tested
- Water exercise program, Land-based-program
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water exercise programOther
The exercise program includes a short foot exercise and will be given in water.
Land-based-programOther
The exercise program includes a short foot exercise and will be given on land.
| Study group | Role | What they receive |
|---|---|---|
| Water exercise program | Experimental | The treatment program includes in-water exercise program. Participants will be exercised twice a week for six weeks. Receives: Other: Water exercise program |
| Land-based-program | Active comparator | The treatment program includes land-based exercise program. Participants will be exercised twice a week for six weeks. Receives: Other: Land-based-program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Posture Index
A widely used method to assess foot posture and classify individuals according to different foot types.
Each criterion is scored on a 5-point scale ranging from -2 to +2.
Measured: 6 weeks
Navicular Drop Test
It is a clinical assessment used to evaluate the degree of foot pronation or flattening of the medial longitudinal arch during weight bearing. It is commonly used to assess foot pronation, especially the vertical displacement of the navicular bone during weight bearing.
Measured: 6 weeks
Biodex Balance System
It is a computerized balance assessment system widely used in clinical and research settings to assess and improve balance and stability. The Biodex Balance System typically consists of a computerized platform with force sensors, visual feedback display and various training modes. It provides quantitative measurements of balance parameters, allowing accurate assessment and monitoring of progress
Measured: 6 weeks
Secondary outcomes (1)
Pittsburg Sleep Index
It is a widely used scale that evaluates sleep quality and disorders related to sleep problems.
The Pitssburg sleep index includes 19 questions Each question is scored from 0 to 3 points, with a high score indicating poor sleep quality. The scale has a total score with a minimum score of 0 and a maximum score of 21 points
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion15 Apr 2024 (estimated)
- Study completion10 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251804
- Sponsor's protocol ID
- 2023-19/03
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Short-Foot Exercises in Water and on Land in Pes Planus
- ClinicalTrials.gov ID
- NCT06251804
- Acronym / sponsor ID
- 2023-19/03
- Conditions
- Pes Planus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 10 Jul 2024 (estimated)
- First posted
- 9 Feb 2024 (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.
Pes planus is caused by the elongation of the intrinsic muscles in the medial arch of the foot, causing the arch to approach the ground or the sole of the foot to touch the ground completely.
Detailed description
For this purpose, in this project, the effectiveness of short foot exercises in water and on land will be compared in young adults with pes planus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water exercise program | Experimental | Other: Water exercise programThe treatment program includes in-water exercise program. Participants will be exercised twice a week for six weeks. |
| Land-based-program | Active comparator | Other: Land-based-programThe treatment program includes land-based exercise program. Participants will be exercised twice a week for six weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between the ages of 18-25
- Having bilateral pes planus
- People with a score of 6 and above on the Foot Posture Index Score
- Individuals with more than 10 millimeters of pronation according to the navicular drop test were included.
Key exclusion criteria (4 listed)
- Rigid pes planus, hallux valgus, hallux rigidus, epin calcanei
- Lower extremity surgery
- Neurological or orthopedic problems and history of disease
- Regular exercise for the treatment of pes planus in the last three months
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 |
|---|---|---|
| Water exercise programThe exercise program includes a short foot exercise and will be given in water. | Other | Water exercise program |
| Land-based-programThe exercise program includes a short foot exercise and will be given on land. | Other | Land-based-program |
Primary outcome
Foot Posture Index
Time frame: 6 weeks
A widely used method to assess foot posture and classify individuals according to different foot types. Each criterion is scored on a 5-point scale ranging from -2 to +2.
Navicular Drop Test
Time frame: 6 weeks
It is a clinical assessment used to evaluate the degree of foot pronation or flattening of the medial longitudinal arch during weight bearing. It is commonly used to assess foot pronation, especially the vertical displacement of the navicular bone during weight bearing.
Biodex Balance System
Time frame: 6 weeks
It is a computerized balance assessment system widely used in clinical and research settings to assess and improve balance and stability. The Biodex Balance System typically consists of a computerized platform with force sensors, visual feedback display and various training modes. It provides quantitative measurements of balance parameters, allowing accurate assessment and monitoring of progress
1 secondary outcome
Pittsburg Sleep Index
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- 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.
Mustafa Emre Kıyık contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water exercise program and Land-based-program in people with Pes Planus, run by Istanbul Medipol University Hospital 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 4 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: status not confirmed, as of the sponsor's last update on 13 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hazal GENÇ, PhD (+905413204291, hazaloksuz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Posture Index (time frame: 6 weeks). The study lists 3 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 13 Feb 2024.