Foot DeformitiesClusterNCT03954301
Using the Hierarchical Cluster Method for Foot Deformities
An observational study of Foot Deformities, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to analyze all of the variables with a Hierarchical Cluster Analysis of Multivariate Statistical Methods to obtain more sensitive results, and also to add a new dimension to the hypothesis included in the study. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Foot Deformities
- What is being tested?
- Anthropometric measures
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2019to 5 Jun 2019
- How long will I take part?
- 2 Months
- 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 24 years
- All sexes
- Adult
Study population: University students
Who may be able to join
- Healthy university students.
- Must be able to walk independently.
Who cannot join
- Students with chronic sprains.
- Students who had undergone lower extremity surgery within the last year.
- Students who use assistive walking devices.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anthropometric and Biomechanical Variables Causing Foot Deformities in Young Individuals, Using the Hierarchical Cluster Method
The aim of this study is to analyze all of the variables with a Hierarchical Cluster Analysis of Multivariate Statistical Methods to obtain more sensitive results, and also to add a new dimension to the hypothesis included in the study.
Read the detailed description
Aim and Introduction: Due to individual anthropometric differences, there are many different types of foot posture Foot posture variations affect lower extremity structure, alignment and biomechanical characteristics. Particularly in younger people, performing critical biomechanical measurements in the lower extremity and foot is extremely important to the detection of, and early intervention in, orthopedic problems that these individuals will encounter in their later life. In the literature, attempts at analysis of the evaluations realized so far have been made by univariate analysis. Considering the relationship between variation and variables, these methods result in loss of information. The aim of this study is to analyze all of the variables with a Hierarchical Cluster Analysis of Multivariate Statistical Methods to obtain more sensitive results, and also to add a new dimension to the hypothesis included in the study.
Methods: The study is carried out on 2nd and 3rd year university students in the physiotherapy and rehabilitation department taking a kinesiology course. The analyses are performed at the Biruni University Physiotherapy and Rehabilitation laboratory. Patients with musculoskeletal system pathomechanics which could prevent standing and walking are not included in the study. After demographic characteristics are recorded, Q, valgity angle, subtalar joint, medial longitudinal arch and hallux valgus angles are measured with a goniometer. The height from the ground of the navicula are calculated by caliper, using the Navicular drop test. Metatarsal width are also calculated with this device. Medial longitudinal arch angle, metatarsal width and nacivular drop tests are performed under weight-bearing and non-weight-bearing conditions.
- Conditions
- Foot Deformities
- Being tested
- Anthropometric measures
- Keywords
- Foot deformities, Cluster method, Kinematic analysis
- Medical subject headings
- Foot Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthropometric measuresDiagnostic test
Also called Kinematic analysis
Q, valgity angle, subtalar joint, medial longitudinal arch and hallux valgus angles were measured with a goniometer. The height from the ground of the navicula was calculated by caliper, using the Navicular drop test. Metatarsal width was also calculated with this device. Medial longitudinal arch angle, metatarsal width and nacivular drop tests were performed under weight-bearing and non-weight-bearing conditions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Navicular drop test
The height of navicula will be measured in weight-bearing and non-weight bearing conditions in millimeters.
Measured: 2 weeks.
Metatarsal width
The width of metatarsal zone will be measured in weight-bearing and non-weight bearing conditions in millimeters.
Measured: 2 weeks.
Subtalar angle
The angle between calcaneus and Achilleus tendon will be measured with goniometer in standing position and the degree will be calculated.
Measured: 2 weeks.
Hallux valgus angle
The angle between 1st metatars and hallux will be measured with goniometer and the degree will be calculated.
Measured: 2 weeks.
Secondary outcomes (2)
Q angle
The angle of quadriceps femoris muscle will be measured with goniometer in supine position and the degree will be assessed.
Measured: 2 weeks.
Medial longitudinal arch angle
The angle between 1st metatarsophalangeal joint, navicula and medial malleol will be measured and the degree will be calculated.
Measured: 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start20 May 2019
- Primary completion30 May 2019
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot DeformitiesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Başar Öztürk, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954301
- Sponsor's protocol ID
- BiruniUni
- Acronym
- Cluster
- Status last verified
- Jan 2020
- First submitted
- 14 May 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- 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 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anthropometric and Biomechanical Variables Causing Foot Deformities in Young Individuals, Using the Hierarchical Cluster Method
- ClinicalTrials.gov ID
- NCT03954301
- Acronym / sponsor ID
- Cluster / BiruniUni
- Conditions
- Foot Deformities
- Keywords
- Foot deformities, Cluster method, Kinematic analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 17 May 2019 (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.
The aim of this study is to analyze all of the variables with a Hierarchical Cluster Analysis of Multivariate Statistical Methods to obtain more sensitive results, and also to add a new dimension to the hypothesis included in the study.
Detailed description
Aim and Introduction: Due to individual anthropometric differences, there are many different types of foot posture Foot posture variations affect lower extremity structure, alignment and biomechanical characteristics. Particularly in younger people, performing critical biomechanical measurements in the lower extremity and foot is extremely important to the detection of, and early intervention in, orthopedic problems that these individuals will encounter in their later life. In the literature, attempts at analysis of the evaluations realized so far have been made by univariate analysis. Considering the relationship between variation and variables, these methods result in loss of information. The aim of this study is to analyze all of the variables with a Hierarchical Cluster Analysis of Multivariate Statistical Methods to obtain more sensitive results, and also to add a new dimension to the hypothesis included in the study.
Methods: The study is carried out on 2nd and 3rd year university students in the physiotherapy and rehabilitation department taking a kinesiology course. The analyses are performed at the Biruni University Physiotherapy and Rehabilitation laboratory. Patients with musculoskeletal system pathomechanics which could prevent standing and walking are not included in the study. After demographic characteristics are recorded, Q, valgity angle, subtalar joint, medial longitudinal arch and hallux valgus angles are measured with a goniometer. The height from the ground of the navicula are calculated by caliper, using the Navicular drop test. Metatarsal width are also calculated with this device. Medial longitudinal arch angle, metatarsal width and nacivular drop tests are performed under weight-bearing and non-weight-bearing conditions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Age groups
- Adult
- Study population
- University students
Key inclusion criteria (2 listed)
- Healthy university students.
- Must be able to walk independently.
Key exclusion criteria (3 listed)
- Students with chronic sprains.
- Students who had undergone lower extremity surgery within the last year.
- Students who use assistive walking devices.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anthropometric measuresAlso: Kinematic analysisQ, valgity angle, subtalar joint, medial longitudinal arch and hallux valgus angles were measured with a goniometer. The height from the ground of the navicula was calculated by caliper, using the Navicular drop test. Metatarsal width was also calculated with this device. Medial longitudinal arch angle, metatarsal width and nacivular drop tests were performed under weight-bearing and non-weight-bearing conditions. | Diagnostic test | – |
Primary outcome
Navicular drop test
Time frame: 2 weeks.
The height of navicula will be measured in weight-bearing and non-weight bearing conditions in millimeters.
Metatarsal width
Time frame: 2 weeks.
The width of metatarsal zone will be measured in weight-bearing and non-weight bearing conditions in millimeters.
Subtalar angle
Time frame: 2 weeks.
The angle between calcaneus and Achilleus tendon will be measured with goniometer in standing position and the degree will be calculated.
Hallux valgus angle
Time frame: 2 weeks.
The angle between 1st metatars and hallux will be measured with goniometer and the degree will be calculated.
2 secondary outcomes
Q angle
Time frame: 2 weeks.
Medial longitudinal arch angle
Time frame: 2 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Foot Deformities, run by Biruni 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 27 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Navicular drop test (time frame: 2 weeks.). The study lists 4 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 27 Jan 2020.