- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04746508
Flat Foot and Coronal Spinopelvic Alignment
February 6, 2021 updated by: Pınar Kısacık, PhD, Hacettepe University
The Influence of Bilateral and Unilateral Flat Foot on Coronal Spinopelvic Alignment in Asymptomatic Young Healthy Males
This study aimed to present the influence of unilateral and bilateral flat foot on coronal spinopelvic alignment in asymptomatic young healthy males.
It will be carried out by examining the medical reports of individuals who apply to the National Health Board to work in positions requiring physical fitness between January 2018 and January 2019.
Plain radiographies of the feet, pelvis, and spine will be analyzed.
Calcaneal pitch angle (CPA) for flat foot, pelvic obliquity (PO), and Cobb angle (CA) for spinal asymmetry will be measured.
After all analyzes were completed, participants will be divided into 2 groups as unilateral (UniFF) or bilateral (BiFF) flat foot, depending on the CPA measurements and will be compared.
Study Overview
Status
Enrolling by invitation
Study Type
Observational
Enrollment (Actual)
360
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey
- Pınar Kısacık
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Healthy individuals who applied to the National Health Boards to work in positions requiring physical fitness between January 2018 and January 2019.
Description
Inclusion Criteria:
- Body mass index (BMI) ranging between 18.5-24.9 kg/m2 (accepted as normal weight by World Health Organisation (WHO))
- Age ranging between 18-25 years
- Male gender
Exclusion Criteria:
- Being older than 25 years
- BMI out of normal weight according to WHO
- Being female
- History of spinal trauma/ surgery
- Having/had spinal disorders like spondylolisthesis, spondylodiscitis, etc.
- Having/had chronic inflammatory arthritis especially spodiloarthrosis (i.e., ankylosing spondylitis, psoriatic arthritis, etc.)
- Having/had a vertebral fracture
- Having/had aseptic necrosis of the vertebra
- Radiographs with inappropriate image qualities.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Unilateral Flat Foot (UniFF)
Participants with flat foot unilaterally (Only one foot's Calcaneal pitch angle ≤ 20 degree)
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Bilateral Flat Foot (BiFF)
Participants with flat foot bilaterally (Both feet's Calcaneal pitch angle ≤ 20 degree)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Calcaneal pitch angle (CPA)
Time Frame: Baseline
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Calcaneal pitch angle (CPA) is defined as an angle between a line drawn from the inferior of the calcaneocuboid joint to the inferior border of the calcaneus and a second line drawn from the inferior aspect of the sesamoid bones to the inferior border (13).
CPA for both (right and left) foot was evaluated from all plain radiographs in this study and the angles equal to or less than 20 degrees were accepted as a flat foot.
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Baseline
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Pelvic obliquity (PO)
Time Frame: Baseline
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Pelvic obliquity (PO) was measured by horizontal pelvic obliquity according to Osebold et al. from a posteroanterior radiograph.
The angle between the line drawn between the most proximal points on the iliac crest and the line drawn parallel to the lower end of the radiograph was recorded.
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Baseline
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The Cobb angle (CA
Time Frame: Baseline
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The Cobb angle (CA) is a gold standard measurement for identifying the magnitude of spinal curves (14).
Spinal curvature was measured from the standing full-length posteroanterior radiograph.
The angle of the curve is measured as an angle between the perpendiculars of the lines parallel to the upper border of the upper vertebral body and parallel to the lower border of the lowest vertebral body of the curve (16).
Straight or symmetrical spines in the coronal plane were accepted as a normal spine, and curves<10 degrees accepted as spinal asymmetry, and the curves ≥ 10 degrees accepted as scoliosis (15).
Spinal curve patterns in coronal planes were classified according to the Scoliosis Research Society classification.
The curve was classified as single in terms of one curve exists in the thoracal or lumbal spine; as double in terms of one curve exist the through thoracal and lumbal spine; and as triple that exists through upper thoracal, middle thoracal and lumbal spine (17).
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pınar Kısacık, PhD, Hacettepe University Faculty of Physical Therapy and Rehabilitation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
January 1, 2019
Study Completion (Anticipated)
March 1, 2021
Study Registration Dates
First Submitted
January 29, 2021
First Submitted That Met QC Criteria
February 6, 2021
First Posted (Actual)
February 9, 2021
Study Record Updates
Last Update Posted (Actual)
February 9, 2021
Last Update Submitted That Met QC Criteria
February 6, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 72300690-799-E17195
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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