NCT03629938

Brief 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. Maximum, minimum values are going to be calculated. The 95% and 68% prediction intervals will be used as cut off limits.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

March 3, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2019

Completed
Last Updated

July 29, 2020

Status Verified

February 1, 2019

Enrollment Period

1 month

First QC Date

July 21, 2018

Last Update Submit

July 28, 2020

Conditions

Keywords

Feiss lineMedial longitudinal archNavicular dropPes planus

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 days

Secondary Outcomes (3)

  • Mean value differences between male and female

    10 days

  • Correlation of arc measurements and standing length

    10 days

  • Medial Longitudinal Arch Cut Off Values

    10 days

Interventions

evaluation and classification of medial longitudinal arch height of foot in adults

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Individuals that ages between 18-60 (adults), healthy male and female

You may qualify if:

  • Being between the ages of 18-40
  • Individuals who voluntarily agree to participate in the study

You may not qualify if:

  • Those who have foot operation
  • Foot trauma story which is causing an anatomic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mustafa Sahin, PhD

    Medipol University

    STUDY CHAIR
  • Gizem Ergezen, MSc

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2018

First Posted

August 14, 2018

Study Start

March 3, 2019

Primary Completion

April 14, 2019

Study Completion

May 28, 2019

Last Updated

July 29, 2020

Record last verified: 2019-02

Locations