Pes PlanusNCT03629938
Evaluation and Classification of Foot Medial Longitudinal Arch Height in Adults
An observational study of Pes Planus, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is, to evaluate and classificate the medial longitudinal arch height in adult individuals. Aged between 18-40 years,350 adults who are voluntarily participate is going to be evaluate with Feiss Line(FL), Navicular Drop(ND) and Longitudinal Arch Angle(LAA) in subtalar neutral and resting position. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pes Planus
- What is being tested?
- evaluation
- How many people
- 350 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2019to 28 May 2019
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals that ages between 18-60 (adults), healthy male and female
Who may be able to join
- Being between the ages of 18-40
- Individuals who voluntarily agree to participate in the study
Who cannot join
- Those who have foot operation
- Foot trauma story which is causing an anatomic disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34810
About this study
Official title: Erişkinlerde Ayak Medial Longitudinal Ark Yüksekliğinin Değerlendirilmesi ve Sınıflandırılması
The aim of the study is, to evaluate and classificate the medial longitudinal arch height in adult individuals. Aged between 18-40 years,350 adults who are voluntarily participate is going to be evaluate with Feiss Line(FL), Navicular Drop(ND) and Longitudinal Arch Angle(LAA) in subtalar neutral and resting position. Maximum, minimum values are going to be calculated. The 95% and 68% prediction intervals will be used as cut off limits.
Read the detailed description
The aim of the study is, to evaluate and classificate the medial longitudinal arch height in adult individuals.
Aged between 18-40 years,350 adults who are voluntarily participate is going to be evaluate with Feiss Line(FL), Navicular Height(NH) and Longitudinal Arch Angle(LAA) in subtalar neutral and resting position. Maximum, minimum values are going to be calculated.
Participant's height, weight and foot length, from posterior aspect of calcaneus to the longest toe's tip, will be measured. Center of the medial malleolus, the navicular tuberosity and the head of the first metatarsal bone will be marked with a CD marker. With these landmarks in foot's relaxed position, neutrally, FL, NH and LAA will be measured by a ruler.
Feiss Line is a drawn line between the center of the medial malleolus to the head of the first metatarsal bone and then perpendicular line distance between this line and the navicular tuberosity will be drawn.The vertical line between the ground and the tubercle indicates Navicular Height. Center of goniometer placed at the navicular tuberosity then goniometer arms follow the medial malleolus and the head of the first metatarsal bone, degree between two arms indicates Longitudinal Arch Angle.
FL, NH, LAA mean values will be calculated. The 95% and 68% prediction intervals will be used as cut off limits.
- Conditions
- Pes Planus
- Being tested
- evaluation
- Keywords
- Feiss line, Medial longitudinal arch, Navicular drop, Pes planus
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluationOther
evaluation and classification of medial longitudinal arch height of foot in adults
What is being measured
The primary outcome is the main question the study is designed to answer.
Medial longitudinal arch height
Navicular Height(NH) mean value, Center of the medial malleolus, the navicular tuberosity and the head of the first metatarsal bone will be marked with a CD marker. With these landmarks in foot's relaxed position, neutrally NH will be measured by a ruler.
The vertical line between the ground and the tubercle indicates Navicular Height. After all data collection, the data will be entered into the Statistical Package for the Social Sciences (SPSS) and the average value calculated.
Measured: 10 days
Secondary outcomes (3)
Mean value differences between male and female
Mean value differences between male and female will be compared statistically with the Statistical Package for the Social Sciences (SPSS) program.
Measured: 10 days
Correlation of arc measurements and standing length
Correlation of arc measurements and standing length will be correlated statistically with the Statistical Package for the Social Sciences (SPSS) program.
Measured: 10 days
Medial Longitudinal Arch Cut Off Values
After average values calculated, cut off values will be generated from the data obtained from the arch height in standard, healthy individuals.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start3 Mar 2019
- Primary completion14 Apr 2019
- Study completion28 May 2019
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mustafa Sahin, PhD, Study chair, Medipol UniversityGizem Ergezen, MSc, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629938
- Sponsor's protocol ID
- 10840098-604.01.01-E.14217
- Status last verified
- Feb 2019
- First submitted
- 21 Jul 2018
- Last updated
- 29 Jul 2020
- 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 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erişkinlerde Ayak Medial Longitudinal Ark Yüksekliğinin Değerlendirilmesi ve Sınıflandırılması
- ClinicalTrials.gov ID
- NCT03629938
- Acronym / sponsor ID
- 10840098-604.01.01-E.14217
- Conditions
- Pes Planus
- Keywords
- Feiss line, Medial longitudinal arch, Navicular drop, Pes planus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 3 Mar 2019 (actual)
- Primary completion
- 14 Apr 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 14 Aug 2018 (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.
The aim of the study is, to evaluate and classificate the medial longitudinal arch height in adult individuals. Aged between 18-40 years,350 adults who are voluntarily participate is going to be evaluate with Feiss Line(FL), Navicular Drop(ND) and Longitudinal Arch Angle(LAA) in subtalar neutral and resting position. Maximum, minimum values are going to be calculated. The 95% and 68% prediction intervals will be used as cut off limits.
Detailed description
The aim of the study is, to evaluate and classificate the medial longitudinal arch height in adult individuals.
Aged between 18-40 years,350 adults who are voluntarily participate is going to be evaluate with Feiss Line(FL), Navicular Height(NH) and Longitudinal Arch Angle(LAA) in subtalar neutral and resting position. Maximum, minimum values are going to be calculated.
Participant's height, weight and foot length, from posterior aspect of calcaneus to the longest toe's tip, will be measured. Center of the medial malleolus, the navicular tuberosity and the head of the first metatarsal bone will be marked with a CD marker. With these landmarks in foot's relaxed position, neutrally, FL, NH and LAA will be measured by a ruler.
Feiss Line is a drawn line between the center of the medial malleolus to the head of the first metatarsal bone and then perpendicular line distance between this line and the navicular tuberosity will be drawn.The vertical line between the ground and the tubercle indicates Navicular Height. Center of goniometer placed at the navicular tuberosity then goniometer arms follow the medial malleolus and the head of the first metatarsal bone, degree between two arms indicates Longitudinal Arch Angle.
FL, NH, LAA mean values will be calculated. The 95% and 68% prediction intervals will be used as cut off limits.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals that ages between 18-60 (adults), healthy male and female
Key inclusion criteria (2 listed)
- Being between the ages of 18-40
- Individuals who voluntarily agree to participate in the study
Key exclusion criteria (2 listed)
- Those who have foot operation
- Foot trauma story which is causing an anatomic 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 |
|---|---|---|
| evaluationevaluation and classification of medial longitudinal arch height of foot in adults | Other | – |
Primary outcome
Medial longitudinal arch height
Time frame: 10 days
Navicular Height(NH) mean value, Center of the medial malleolus, the navicular tuberosity and the head of the first metatarsal bone will be marked with a CD marker. With these landmarks in foot's relaxed position, neutrally NH will be measured by a ruler. The vertical line between the ground and the tubercle indicates Navicular Height. After all data collection, the data will be entered into the Statistical Package for the Social Sciences (SPSS) and the average value calculated.
3 secondary outcomes
Mean value differences between male and female
Time frame: 10 days
Correlation of arc measurements and standing length
Time frame: 10 days
Medial Longitudinal Arch Cut Off Values
Time frame: 10 days
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 29 Jul 2020.
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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 Sahin, PhD study chair
Medipol University
Gizem Ergezen, MSc principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 inclusion and 2 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 29 Jul 2020. 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?
Medial longitudinal arch height (time frame: 10 days). 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 29 Jul 2020.