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Evaluation and Classification of Foot Medial Longitudinal Arch Height in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03629938
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Istanbul Medipol University Hospital

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.

Condition or disease Intervention/treatment
Pes Planus Other: evaluation

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 350 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Erişkinlerde Ayak Medial Longitudinal Ark Yüksekliğinin Değerlendirilmesi ve Sınıflandırılması
Actual Study Start Date : March 3, 2019
Actual Primary Completion Date : April 14, 2019
Actual Study Completion Date : May 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health


Intervention Details:
  • Other: evaluation
    evaluation and classification of medial longitudinal arch height of foot in adults


Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Mean value differences between male and female [ Time Frame: 10 days ]
    Mean value differences between male and female will be compared statistically with the Statistical Package for the Social Sciences (SPSS) program.

  2. Correlation of arc measurements and standing length [ Time Frame: 10 days ]
    Correlation of arc measurements and standing length will be correlated statistically with the Statistical Package for the Social Sciences (SPSS) program.

  3. Medial Longitudinal Arch Cut Off Values [ Time Frame: 10 days ]
    After average values calculated, cut off values will be generated from the data obtained from the arch height in standard, healthy individuals.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Individuals that ages between 18-60 (adults), healthy male and female
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629938


Locations
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Turkey
Istanbul Medipol University
Istanbul, Beykoz, Turkey, 34810
Sponsors and Collaborators
Istanbul Medipol University Hospital
Investigators
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Study Chair: Mustafa Sahin, PhD Medipol University
Principal Investigator: Gizem Ergezen, MSc Medipol University
Additional Information:

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Responsible Party: Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier: NCT03629938    
Other Study ID Numbers: 10840098-604.01.01-E.14217
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istanbul Medipol University Hospital:
Feiss line
Medial longitudinal arch
Navicular drop
Pes planus
Additional relevant MeSH terms:
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Flatfoot
Talipes
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities