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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03629938
Other study ID # 10840098-604.01.01-E.14217
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 3, 2019
Est. completion date May 28, 2019

Study information

Verified date February 2019
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date May 28, 2019
Est. primary completion date April 14, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Istanbul Medipol University Istanbul Beykoz

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 10 days
Secondary 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. 10 days
Secondary 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. 10 days
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