- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05281432
Balance in Individuals With Pes Planus
Evaluation of Balance in Individuals Diagnosed With Pes Planus
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34000
- Istanbul Medipol University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Pes planus individuals
The aim of this study was to evaluate the static and dynamic balance status of male individuals diagnosed with pes planus.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Tandem Posture Test;
Time Frame: 3 minutes
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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.
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3 minutes
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Romberg Balance Test
Time Frame: 3 minutes
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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.
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3 minutes
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One Leg Standing Test
Time Frame: 2 minutes
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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.
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2 minutes
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Timed Get Up and Go Test (ZKYT)
Time Frame: 5 minutes
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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.
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5 minutes
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Berg Balance Test
Time Frame: 2 minutes
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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
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2 minutes
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Tinetti Balance Evaluation Scale
Time Frame: 5 minutes
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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.
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5 minutes
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Collaborators and Investigators
Investigators
- Study Director: Mehmet Sa TAN, Msc, Istanbul Medipol University, Department of Physiotherapy and Rehabilitation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-604.01.01-63688
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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