FlatfootNCT05616637
Investigation of Inter-rater and Test-retest Reliability of Y Balance Test in Individuals With Pes Planus
An observational study of Flatfoot, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
Trial summary
Pes Planus is characterized by the descent of the medial longitudinal arch, eversion of the hindfoot, and dorsiflexion and abduction of the midfoot. Disorders in the bones of the foot, dysfunction of the tibialis posterior muscle, shortness of the Achilles tendon or weakness in the muscles may pose a risk for pes… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Flatfoot
- What is being tested?
- Navicular Drop Test, Lower Extremity Length Measurement and Y Balance Test
- How many people
- 19 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2022to 28 Feb 2023
- 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 40 years
- All sexes
- Adult
Study population: Young adults aged 18-40, with pes planus and volunteering to participate in the study will be included in the study.
Who may be able to join
- Volunteering to participate in the study,
- Being between the ages of 18-40,
- Having pes planus.
Who cannot join
- Having had lower extremity or spine surgery,
- Having a neurological or rheumatic disease,
- Having a problem with vision and hearing,
- Having suffered a lower extremity injury in the last 1 year,
- Presence of acute or chronic pain,
- Regular participation in sports activities,
Show all 10Show fewer
- Being pregnant,
- Ambulation with an assistive device,
- Active participation in treatment,
- Presence of lower extremity inequality.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Gelisim University
Istanbul, Avcılar, 34000
About this study
Official title: Investigation of Inter-rater and Test-retest Reliability of Y Balance Test in Assessment of Dynamic Balance in Individuals With Pes Planus
Pes Planus is characterized by the descent of the medial longitudinal arch, eversion of the hindfoot, and dorsiflexion and abduction of the midfoot. Disorders in the bones of the foot, dysfunction of the tibialis posterior muscle, shortness of the Achilles tendon or weakness in the muscles may pose a risk for pes planus.
In a study in which 80 female participants aged 65 and over participated voluntarily, it was shown that 90% of the deformities seen in the foot were pes planus. In another study conducted with adults aged 18-21 years, pes planus was found with a rate of 13.6%. In a study in a group of 500 people aged 18-25 years, this rate was found to be 29%.
Read more
Since exercise, physical activity and walking for a long time will cause foot and leg pain in people with pes planus, the level of physical activity of these people may be limited. There are studies examining the relationship between pes planus and different physical parameters. It has been determined as a result of some studies that the balance, which is one of these parameters, is negatively affected by the presence of pes planus.
According to the literature, many studies have used the Y test in the evaluation of dynamic balance in individuals with pes planus. However the reliability of the Y Balance Test, which is a valid and reliable method for assessing balance in healthy individuals, has not been found in individuals with pes planus.
- Conditions
- Flatfoot
- Being tested
- Navicular Drop Test, Lower Extremity Length Measurement, Y Balance Test
- Keywords
- Postural Balance, Reproducibility of Results
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navicular Drop TestDiagnostic test
While participants in sitting position, the navicular tuberosity (NT) will be palpated.The most distal protruding portion of the medial NT will be marked. Participants will be asked to stand with equal weight on both feet. The new distance will be measured. The navicular drop test (NDT) results will then be obtained by comparing the measured values between the sitting and standing positions. Each measurement will be repeated three times and the average of the 3 measurements will be calculated. The expression in mm of the distance between the two marks will be considered the amount of ND. The amount of navicular fall of 10 mm or more will be interpreted as pes planus. Measurements will be made on both extremities. As a result of the measurements, if pes planus is present in a single extremity, that extremity, if it is present in both extremities, the extremity with higher NDT or if it is equal on both sides, the dominant extremity will be tested.
Lower Extremity Length MeasurementOther
Lower extremity length will be recorded to normalize dynamic balance test data. The person will lie in the supine position. The distance between the umbilicus and the anterior superior of the spina iliaca will be measured in cm with the help of a tape measure. If there is no asymmetry, it will be assumed that there is no rotation in the pelvis, and it will be started to measure the length of the lower extremity. If pelvic asymmetry is detected, the pelvic position will be corrected manually. Then, the most inferior point of the spina iliaca anterior superior and the most distal point of the medial malleolus will be marked and measured and recorded. Lower extremity length and data in 3 different directions will be used in cm. The purpose of using formulas is to easily provide comparisons with other studies using the same type of data. The data obtained from the formula is expressed as a percentage of the length of the limb.
Y Balance TestOther
While the individual tries to balance on one bare foot at the midpoint of the assembly, the individual will also be asked to reach as far as possible with the other foot in the anterior, posteromedial and posterolateral directions, touch the tip of the toe, and then immediately return to the starting position without disturbing the balance. The test will be evaluated for 3 repetitions. Situations where the participant will be requested to repeat the test: the foot on the ground passes the reference point or the heel lifts off the ground, perturbations caused by the environment, contact of the foot with the ground, and loss of balance when returning to the starting position. 10 seconds between 3 repetitions during testing will be given. Each participant will be given the right to try 6 times before starting the test in order to eliminate the possible learning parameter. The test will be repeated 3 times in each direction and the closest distance in cm will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Pes Planus | Participants with unilateral pes planus aged 18-40 years will be included in the study. Receives: Diagnostic Test: Navicular Drop Test; Other: Lower Extremity Length Measurement; Other: Y Balance Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Y Balance Test
Dynamic Balance Test
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start10 Dec 2022
- Primary completion24 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FlatfootStudies 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
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Gelisim University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Bilgi University, Beykoz University
- Responsible party
- Principal investigator, Engin Caglar, Istanbul Gelisim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616637
- Sponsor's protocol ID
- PP002
- Status last verified
- Apr 2023
- First submitted
- 8 Nov 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim JA, Lim OB, Yi CH. Difference in static and dynamic stability between flexible flatfeet and neutral feet. Gait Posture. 2015 Feb;41(2):546-50. doi: 10.1016/j.gaitpost.2014.12.012. Epub 2014 Dec 22.
PubMed 25560044Kim EK, Kim JS. The effects of short foot exercises and arch support insoles on improvement in the medial longitudinal arch and dynamic balance of flexible flatfoot patients. J Phys Ther Sci. 2016 Nov;28(11):3136-3139. doi: 10.1589/jpts.28.3136. Epub 2016 Nov 29.
PubMed 27942135Alam F, Raza S, Moiz JA, Bhati P, Anwer S, Alghadir A. Effects of selective strengthening of tibialis posterior and stretching of iliopsoas on navicular drop, dynamic balance, and lower limb muscle activity in pronated feet: A randomized clinical trial. Phys Sportsmed. 2019 Sep;47(3):301-311. doi: 10.1080/00913847.2018.1553466. Epub 2018 Dec 5.
PubMed 30517043Alshehre Y, Alkhathami K, Brizzolara K, Weber M, Wang-Price S. Reliability and Validity of the Y-balance Test in Young Adults with Chronic Low Back Pain. Int J Sports Phys Ther. 2021 Jun 1;16(3):628-635. doi: 10.26603/001c.23430.
PubMed 34123515
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Inter-rater and Test-retest Reliability of Y Balance Test in Assessment of Dynamic Balance in Individuals With Pes Planus
- ClinicalTrials.gov ID
- NCT05616637
- Acronym / sponsor ID
- PP002
- Conditions
- Flatfoot
- Keywords
- Postural Balance, Reproducibility of Results
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Istanbul Gelisim UniversityUniversity, hospital or other
- Collaborators
- Istanbul Bilgi University, Beykoz University
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 15 Nov 2022 (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.
Pes Planus is characterized by the descent of the medial longitudinal arch, eversion of the hindfoot, and dorsiflexion and abduction of the midfoot. Disorders in the bones of the foot, dysfunction of the tibialis posterior muscle, shortness of the Achilles tendon or weakness in the muscles may pose a risk for pes planus.
In a study in which 80 female participants aged 65 and over participated voluntarily, it was shown that 90% of the deformities seen in the foot were pes planus. In another study conducted with adults aged 18-21 years, pes planus was found with a rate of 13.6%. In a study in a group of 500 people aged 18-25 years, this rate was found to be 29%.
Since exercise, physical activity and walking for a long time will cause foot and leg pain in people with pes planus, the level of physical activity of these people may be limited. There are studies examining the relationship between pes planus and different physical parameters. It has been determined as a result of some studies that the balance, which is one of these parameters, is negatively affected by the presence of pes planus.
According to the literature, many studies have used the Y test in the evaluation of dynamic balance in individuals with pes planus. However the reliability of the Y Balance Test, which is a valid and reliable method for assessing balance in healthy individuals, has not been found in individuals with pes planus.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pes Planus | – | Diagnostic Test: Navicular Drop Test, Other: Lower Extremity Length Measurement, Other: Y Balance TestParticipants with unilateral pes planus aged 18-40 years will be included in the study. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- Young adults aged 18-40, with pes planus and volunteering to participate in the study will be included in the study.
Key inclusion criteria (3 listed)
- Volunteering to participate in the study,
- Being between the ages of 18-40,
- Having pes planus.
Key exclusion criteria (10 listed)
- Having had lower extremity or spine surgery,
- Having a neurological or rheumatic disease,
- Having a problem with vision and hearing,
- Having suffered a lower extremity injury in the last 1 year,
- Presence of acute or chronic pain,
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 |
|---|---|---|
| Navicular Drop TestWhile participants in sitting position, the navicular tuberosity (NT) will be palpated.The most distal protruding portion of the medial NT will be marked. Participants will be asked to stand with equal weight on both feet. The new distance will be measured. The navicular drop test (NDT) results will then be obtained by comparing the measured values between the sitting and standing positions. Each measurement will be repeated three times and the average of the 3 measurements will be calculated. The expression in mm of the distance between the two marks will be considered the amount of ND. The amount of navicular fall of 10 mm or more will be interpreted as pes planus. Measurements will be made on both extremities. As a result of the measurements, if pes planus is present in a single extremity, that extremity, if it is present in both extremities, the extremity with higher NDT or if it is equal on both sides, the dominant extremity will be tested. | Diagnostic test | Pes Planus |
| Lower Extremity Length MeasurementLower extremity length will be recorded to normalize dynamic balance test data. The person will lie in the supine position. The distance between the umbilicus and the anterior superior of the spina iliaca will be measured in cm with the help of a tape measure. If there is no asymmetry, it will be assumed that there is no rotation in the pelvis, and it will be started to measure the length of the lower extremity. If pelvic asymmetry is detected, the pelvic position will be corrected manually. Then, the most inferior point of the spina iliaca anterior superior and the most distal point of the medial malleolus will be marked and measured and recorded. Lower extremity length and data in 3 different directions will be used in cm. The purpose of using formulas is to easily provide comparisons with other studies using the same type of data. The data obtained from the formula is expressed as a percentage of the length of the limb. | Other | Pes Planus |
| Y Balance TestWhile the individual tries to balance on one bare foot at the midpoint of the assembly, the individual will also be asked to reach as far as possible with the other foot in the anterior, posteromedial and posterolateral directions, touch the tip of the toe, and then immediately return to the starting position without disturbing the balance. The test will be evaluated for 3 repetitions. Situations where the participant will be requested to repeat the test: the foot on the ground passes the reference point or the heel lifts off the ground, perturbations caused by the environment, contact of the foot with the ground, and loss of balance when returning to the starting position. 10 seconds between 3 repetitions during testing will be given. Each participant will be given the right to try 6 times before starting the test in order to eliminate the possible learning parameter. The test will be repeated 3 times in each direction and the closest distance in cm will be recorded. | Other | Pes Planus |
Primary outcome
Y Balance Test
Time frame: Baseline
Dynamic Balance Test
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 6 Apr 2023.
- Background: PubMed 25560044Kim JA, Lim OB, Yi CH. Difference in static and dynamic stability between flexible flatfeet and neutral feet. Gait Posture. 2015 Feb;41(2):546-50. doi: 10.1016/j.gaitpost.2014.12.012. Epub 2014 Dec 22.
- Background: PubMed 27942135Kim EK, Kim JS. The effects of short foot exercises and arch support insoles on improvement in the medial longitudinal arch and dynamic balance of flexible flatfoot patients. J Phys Ther Sci. 2016 Nov;28(11):3136-3139. doi: 10.1589/jpts.28.3136. Epub 2016 Nov 29.
- Background: PubMed 30517043Alam F, Raza S, Moiz JA, Bhati P, Anwer S, Alghadir A. Effects of selective strengthening of tibialis posterior and stretching of iliopsoas on navicular drop, dynamic balance, and lower limb muscle activity in pronated feet: A randomized clinical trial. Phys Sportsmed. 2019 Sep;47(3):301-311. doi: 10.1080/00913847.2018.1553466. Epub 2018 Dec 5.
- Background: PubMed 34123515Alshehre Y, Alkhathami K, Brizzolara K, Weber M, Wang-Price S. Reliability and Validity of the Y-balance Test in Young Adults with Chronic Low Back Pain. Int J Sports Phys Ther. 2021 Jun 1;16(3):628-635. doi: 10.26603/001c.23430.
- 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 Flatfoot, run by Istanbul Gelisim 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 10 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 6 Apr 2023. 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?
Y Balance Test (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05616637, which also lists 4 linked publications.
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 6 Apr 2023.