Balance in Individuals With Pes Planus

Pes Planus Clinical Trial

Official title:

Evaluation of Balance in Individuals Diagnosed With Pes Planus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05281432
• Other study ID #: E-10840098-604.01.01-63688
• Status: Completed
• Start date: April 12, 2019
• Est. completion date: February 20, 2022

Study information

• Verified date: March 2022
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 20, 2022
• Est. primary completion date: May 25, 2021
• Gender: All
• Age group: 30 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Flatfoot
• Pes Planus

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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