NCT04746508

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

January 29, 2021

Last Update Submit

February 6, 2021

Conditions

Keywords

Flat footpelvic obliquityspinal asymmetryCobb anglecalcaneal pitch angle

Outcome Measures

Primary Outcomes (3)

  • Calcaneal pitch angle (CPA)

    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.

    Baseline

  • Pelvic obliquity (PO)

    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.

    Baseline

  • The Cobb angle (CA

    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).

    Baseline

Study Arms (2)

Unilateral Flat Foot (UniFF)

Participants with flat foot unilaterally (Only one foot's Calcaneal pitch angle ≤ 20 degree)

Bilateral Flat Foot (BiFF)

Participants with flat foot bilaterally (Both feet's Calcaneal pitch angle ≤ 20 degree)

Eligibility Criteria

Age18 Years - 25 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pınar Kısacık

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FlatfootSpinal Curvatures

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pınar Kısacık, PhD

    Hacettepe University Faculty of Physical Therapy and REhabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 9, 2021

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

March 1, 2021

Last Updated

February 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations