Flat Foot [Pes Planus] (Acquired), Left FootNCT04746508
Flat Foot and Coronal Spinopelvic Alignment
An observational study of Flat Foot [Pes Planus] (Acquired), Left Foot and Flat Foot [Pes Planus] (Acquired), Right Foot, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Flat Foot [Pes Planus] (Acquired), Left Foot, Flat Foot [Pes Planus] (Acquired), Right Foot, Flat Foot Acquired Bilateral (Pes Planus)
- How many people
- 360 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy individuals who applied to the National Health Boards to work in positions requiring physical fitness between January 2018 and January 2019.
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 9Show fewer
- Having/had a vertebral fracture
- Having/had aseptic necrosis of the vertebra
- Radiographs with inappropriate image qualities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Flat Foot [Pes Planus] (Acquired), Left Foot, Flat Foot [Pes Planus] (Acquired), Right Foot, Flat Foot Acquired Bilateral (Pes Planus), Pelvic Obliquity, Spinal Curvatures
- Keywords
- Flat foot, pelvic obliquity, spinal asymmetry, Cobb angle, calcaneal pitch angle
- Medical subject headings
- Flatfoot, Spinal Curvatures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Jan 2018
- Primary completion1 Jan 2019
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flat Foot [Pes Planus] (Acquired), Left FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kısacık, PhD, Hacettepe University
- Investigators
- Pınar Kısacık, PhD, Principal investigator, Hacettepe University Faculty of Physical Therapy and REhabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746508
- Sponsor's protocol ID
- 72300690-799-E17195
- Status last verified
- Feb 2021
- First submitted
- 29 Jan 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Bilateral and Unilateral Flat Foot on Coronal Spinopelvic Alignment in Asymptomatic Young Healthy Males
- ClinicalTrials.gov ID
- NCT04746508
- Acronym / sponsor ID
- 72300690-799-E17195
- Conditions
- Flat Foot [Pes Planus] (Acquired), Left Foot, Flat Foot [Pes Planus] (Acquired), Right Foot, Flat Foot Acquired Bilateral (Pes Planus), Pelvic Obliquity, Spinal Curvatures
- Keywords
- Flat foot, pelvic obliquity, spinal asymmetry, Cobb angle, calcaneal pitch angle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy individuals who applied to the National Health Boards to work in positions requiring physical fitness between January 2018 and January 2019.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Calcaneal pitch angle (CPA)
Time frame: Baseline
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.
Pelvic obliquity (PO)
Time frame: Baseline
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.
The Cobb angle (CA
Time frame: Baseline
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pınar Kısacık, PhD principal investigator
Hacettepe University Faculty of Physical Therapy and REhabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Flat Foot [Pes Planus] (Acquired), Left Foot and Flat Foot [Pes Planus] (Acquired), Right Foot, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calcaneal pitch angle (CPA) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.