Pes PlanusNCT05281432
Balance in Individuals With Pes Planus
An observational study of Pes Planus, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Pes planus, one of the most common biomechanical disorders in the lower extremities, negatively affects the daily life of the individual and their competence in activities. The aim of this study was to evaluate the static and dynamic balance status of male individuals diagnosed with pes planus. Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Pes Planus
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Apr 2019to 20 Feb 2022
- How long will I take part?
- 12 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 30 to 45 years
- All sexes
- Adult
Study population: Twenty-two volunteers with pes planus and 23 volunteers without pes planus in the 30-45 age group were included in the study. The individuals constituting the pes planus group were formed by a single physiotherapist with clinical experience in pes planus, taking the Feiss line as a criterion, and individuals with pes planus at the 2nd and 3rd levels.
Who may be able to join
- Healthy volunteers, aged between 30-45 years, have not had any lower extremity injury in the last 6 months, have not had any chronic lower extremity pain, have not undergone any lower extremity surgery, and have signed an informed consent form.
Who cannot join
- Those with central nervous system and visual pathology that may affect balance, patients with vestibular pathology, deformities in the waist, hip or knee joints, amputation in the lower extremity, history of lower extremity surgery, malignancy affecting the lower extremity, those who cannot communicate, those who use assistive walking devices are obese patients were not included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Balance in Individuals Diagnosed With Pes Planus
Pes planus, one of the most common biomechanical disorders in the lower extremities, negatively affects the daily life of the individual and their competence in activities. The aim of this study was to evaluate the static and dynamic balance status of male individuals diagnosed with pes planus.
Read the detailed description
METHODS: 22 volunteer patients diagnosed with pes planus in Medipol Mega University Hospital Physical Therapy and Rehabilitation Clinic will be included in the study. This study was approved by Medipol University Non-Interventional Clinical Research Ethics Committee at the meeting numbered 10840098-604.01.01-E.63688 with decision number 1027. approved. The signatures of the participants included in the study were given with the "Informed Voluntary Consent Form". Oral and written about the research.
With the "Participant Diagnosis Form", the person's name-surname, age, gender, height, weight, body mass index, contact number, Pes Planus degree, whether he has a diagnosed disease, whether he has a past disability or whether he has had surgery will be questioned. .
In the 30-45 age group, 22 volunteers with pes planus and 24 volunteers without pes planus will be included in the study. Individuals in the pes planus group will be formed at the 2nd and 3rd levels by a single physiotherapist with clinical experience, based on the Feiss line in pes planus.
- Conditions
- Pes Planus
- Keywords
- Pes Planus, Balance, Static Balance, Dynamic Balance
- Medical subject headings
- Flatfoot
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 |
|---|---|---|
| Pes planus individuals | The aim of this study was to evaluate the static and dynamic balance status of male individuals diagnosed with pes planus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tandem Posture Test;
Tandem Posture test; It is a test that evaluates the static balance in which the area in contact with the ground is narrowed. After wearing the appropriate shoelaces, it is requested that one foot touches the heel of the other net and stand for 30 seconds without support. At this time, the arms are kept close to the body. It starts with the command and the tandem position is maintained until the command stops. 30 seconds or more of the stance test is successful, 30 seconds of the test is positive, and 10 seconds or less indicates the risk of falling.
Measured: 3 minutes
Romberg Balance Test
Romberg Balance Test; The person stands upright with his feet parallel and then closes his eyes for 20-30 seconds. The tester decides on the amount of shaking subjectively. Excessive rocking or stepping during the test indicates loss of balance. If he cannot maintain this position and loses his balance, the test is positive. The same test can be performed with one foot slightly flexed at the hip and knee.
Measured: 3 minutes
One Leg Standing Test
One Leg Standing Test; This test serves to measure balance and static standing ability. It gives information about the risk of falling of individuals. Static balances of individuals are measured by recording the duration of standing on one leg. Eyes open first. It is tried on both legs one by one. Eyes are closed and waited for 30 seconds. 2 to 4 repetitions are allowed to record the highest performance. With the eyes closed, the longest time achieved is taken into account.
Measured: 2 minutes
Timed Get Up and Go Test (ZKYT)
Timed Get Up and Go Test (ZKYT); The person was asked to get up from the chair he was sitting in, to walk 3 meters at a safe and normal speed, to turn, to walk back, to sit back on the chair, and the time was recorded in seconds (sec). The test is initiated with the patient's feet flat on the floor and their arms resting on the armrest of the chair. Perform three repetitions and record the best result.
Measured: 5 minutes
Berg Balance Test
Berg Balance Test; 14 proposals and each instruction score between 0-4, 0 points when the patient cannot do the activity at all, 4 points are given when he/she completes the activity independently, The highest score is 56,0-20 points balance disorder, 21-40 points acceptable balance, 41- 56 points indicate the presence of good balance. Score <45 associated with increased risk of falling
Measured: 2 minutes
Tinetti Balance Evaluation Scale
Tinetti Balance Evaluation Scale; Tinetti is a very important test in the evaluation of balance and gait and in the evaluation of the management of daily life alone. Tinetti scale balance score is maximum 16 points, walking score is maximum 12 points, for a total of 28 points.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start12 Apr 2019
- Primary completion25 May 2021
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pes PlanusStudies 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
- Prospective
- Enrolment
- 48 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehmet Sa TAN, Msc, Study director, Istanbul Medipol University, Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281432
- Sponsor's protocol ID
- E-10840098-604.01.01-63688
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 16 Mar 2022
- 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 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Balance in Individuals Diagnosed With Pes Planus
- ClinicalTrials.gov ID
- NCT05281432
- Acronym / sponsor ID
- E-10840098-604.01.01-63688
- Conditions
- Pes Planus
- Keywords
- Pes Planus, Balance, Static Balance, Dynamic Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 16 Mar 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, one of the most common biomechanical disorders in the lower extremities, negatively affects the daily life of the individual and their competence in activities. The aim of this study was to evaluate the static and dynamic balance status of male individuals diagnosed with pes planus.
Detailed description
METHODS: 22 volunteer patients diagnosed with pes planus in Medipol Mega University Hospital Physical Therapy and Rehabilitation Clinic will be included in the study. This study was approved by Medipol University Non-Interventional Clinical Research Ethics Committee at the meeting numbered 10840098-604.01.01-E.63688 with decision number 1027. approved. The signatures of the participants included in the study were given with the "Informed Voluntary Consent Form". Oral and written about the research.
With the "Participant Diagnosis Form", the person's name-surname, age, gender, height, weight, body mass index, contact number, Pes Planus degree, whether he has a diagnosed disease, whether he has a past disability or whether he has had surgery will be questioned. .
In the 30-45 age group, 22 volunteers with pes planus and 24 volunteers without pes planus will be included in the study. Individuals in the pes planus group will be formed at the 2nd and 3rd levels by a single physiotherapist with clinical experience, based on the Feiss line in pes planus.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pes planus individuals | – | –The aim of this study was to evaluate the static and dynamic balance status of male individuals diagnosed with pes planus. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- Twenty-two volunteers with pes planus and 23 volunteers without pes planus in the 30-45 age group were included in the study. The individuals constituting the pes planus group were formed by a single physiotherapist with clinical experience in pes planus, taking the Feiss line as a criterion, and individuals with pes planus at the 2nd and 3rd levels.
Key inclusion criteria (1 listed)
- Healthy volunteers, aged between 30-45 years, have not had any lower extremity injury in the last 6 months, have not had any chronic lower extremity pain, have not undergone any lower extremity surgery, and have signed an informed consent form.
Key exclusion criteria (1 listed)
- Those with central nervous system and visual pathology that may affect balance, patients with vestibular pathology, deformities in the waist, hip or knee joints, amputation in the lower extremity, history of lower extremity surgery, malignancy affecting the lower extremity, those who cannot communicate, those who use assistive walking devices are obese patients were not included.
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
Tandem Posture Test;
Time frame: 3 minutes
Tandem Posture test; It is a test that evaluates the static balance in which the area in contact with the ground is narrowed. After wearing the appropriate shoelaces, it is requested that one foot touches the heel of the other net and stand for 30 seconds without support. At this time, the arms are kept close to the body. It starts with the command and the tandem position is maintained until the command stops. 30 seconds or more of the stance test is successful, 30 seconds of the test is positive, and 10 seconds or less indicates the risk of falling.
Romberg Balance Test
Time frame: 3 minutes
Romberg Balance Test; The person stands upright with his feet parallel and then closes his eyes for 20-30 seconds. The tester decides on the amount of shaking subjectively. Excessive rocking or stepping during the test indicates loss of balance. If he cannot maintain this position and loses his balance, the test is positive. The same test can be performed with one foot slightly flexed at the hip and knee.
One Leg Standing Test
Time frame: 2 minutes
One Leg Standing Test; This test serves to measure balance and static standing ability. It gives information about the risk of falling of individuals. Static balances of individuals are measured by recording the duration of standing on one leg. Eyes open first. It is tried on both legs one by one. Eyes are closed and waited for 30 seconds. 2 to 4 repetitions are allowed to record the highest performance. With the eyes closed, the longest time achieved is taken into account.
Timed Get Up and Go Test (ZKYT)
Time frame: 5 minutes
Timed Get Up and Go Test (ZKYT); The person was asked to get up from the chair he was sitting in, to walk 3 meters at a safe and normal speed, to turn, to walk back, to sit back on the chair, and the time was recorded in seconds (sec). The test is initiated with the patient's feet flat on the floor and their arms resting on the armrest of the chair. Perform three repetitions and record the best result.
Berg Balance Test
Time frame: 2 minutes
Berg Balance Test; 14 proposals and each instruction score between 0-4, 0 points when the patient cannot do the activity at all, 4 points are given when he/she completes the activity independently, The highest score is 56,0-20 points balance disorder, 21-40 points acceptable balance, 41- 56 points indicate the presence of good balance. Score <45 associated with increased risk of falling
Tinetti Balance Evaluation Scale
Time frame: 5 minutes
Tinetti Balance Evaluation Scale; Tinetti is a very important test in the evaluation of balance and gait and in the evaluation of the management of daily life alone. Tinetti scale balance score is maximum 16 points, walking score is maximum 12 points, for a total of 28 points.
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 16 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Pes Planus
Recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
Pes Planus
Not yet recruiting
Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients
Hamstring Muscle Strain, Adult Acquired Flatfoot Deformity
Not yet recruiting
The Corrective Power of Subtalar Arthrodesis With Mini/Medial Bone Block (SAMBB) in Patients Affected by Progressive Collapsing Foot Deformity (PCFD): Analysis Using Weight-bearing Cone Beam CT.
Flat Foot
Not yet recruitingObservational study
Tibialis Posterior Muscle Morphology in Flexible Flatfeet Subjects
Flexible Flatfoot
Recruiting
Plantar Stimulation, Whole-Body Vibration, and Baduanjin for Muscle Activation
Flat Feet, Lower-Limb Muscle Activation
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.
Mehmet Sa TAN, Msc study director
Istanbul Medipol University, Department of Physiotherapy 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 Pes Planus, run by Istanbul Medipol University Hospital 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 1 inclusion and 1 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 16 Mar 2022. 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?
Tandem Posture Test; (time frame: 3 minutes). The study lists 6 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 16 Mar 2022.