NCT05281432

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

2.1 years

First QC Date

March 3, 2022

Last Update Submit

March 15, 2022

Conditions

Keywords

Pes Planus, Balance, Static Balance, Dynamic Balance

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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

    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.

    5 minutes

Study Arms (1)

Pes planus individuals

The aim of this study was to evaluate the static and dynamic balance status of male individuals diagnosed with pes planus.

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mehmet Sa TAN, Msc

    Istanbul Medipol University, Department of Physiotherapy and Rehabilitation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 16, 2022

Study Start

April 12, 2019

Primary Completion

May 25, 2021

Study Completion

February 20, 2022

Last Updated

March 16, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations