Validity and Reliability of the Newly Developed Balance Assessment System in Healthy Young Adults

NCT06224374 | Unknown

• 1 other identifier: AkyurekE3
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to to evaluate the validity and reliability of the "Postural Stability Test", "Stability Limits Test", "Sensory Integration Test" and "One-Leg Standing Test" tests of the newly developed patented balance assessment system in healthy young adults. The main questions it aims to answer are:

• Are the "Postural Stability Test", "Stability Limits Test", "Sensory Integration Test" and "One-Leg Standing Test" tests in the newly developed balance assessment system a valid method for healthy young adults?
• Are the "Postural Stability Test", "Stability Limits Test", "Sensory Integration Test" and "One-Leg Standing Test" tests in the newly developed balance assessment system a reliable method for healthy young adults? Participants will be evaluated with the "Postural Stability Test", "Limits of Stability Test", "Sensory Integration Test" and "Bilateral Comparison Test" within the AlBalance Balance Evaluation System and Biodex Balance Evaluation System. Participants will be asked to sit in a chair and rest for 5 minutes before starting the tests. To calculate the test-retest reliability and validity of the devices, these measurements will be made by the same evaluator in two sessions, 7 days apart. To eliminate the learning effect, participants who try AlBalance first in the first session will try Biodex first in the second session (reverse test order will be used). Participants who complete all evaluations with the first device will rest for 5 minutes and move on to the other device. Then, parallel clinical tests will be applied to the participants, "Functional Reaching Test" and "One Leg Standing Test".

Conditions

Healthy; Assessment, Self

Keywords

young adult; healthy; balance; validity; assessment

Outcome Measures

Primary Outcomes (6)

• Postural Stability Test

  Stability indices represent fluctuations around the zero point established before testing when the platform is stable. With the "Postural Stability Test", the anteroposterior, right-left, and general stability indexes of the cases will be recorded. During the test, participants will be asked to stand on the force platform with their feet in a comfortable position, arms at their sides, and palms facing toward the thighs. All measurements will be made with bare feet, and without shoes, and foot position will be recorded using coordinates on the platform's grid to ensure consistency in testing. The participant will be asked to stand still looking at the screen in front of him for 30 seconds. In both devices, there will be a 1-minute rest break between measurements and they will be performed 3 times. The participant's postural stability will be assessed with postural stability test.

  Change from baseline to 7 day

• Limits of Stability

  In this test, the participant stands on force plates and deliberately shifts his or her body weight in the direction indicated on the screen without lifting his or her feet off the ground. This protocol measures various movement characteristics in 8 different directions: front, forward/right, right, back/right, back, back/left, left, and forward/left. During the test, participants will be asked to stand on the force platform with their feet in a comfortable position, arms at their sides, and palms facing toward the thighs. Direction control (%) and test times (sec) in all directions of the participants, who will move in 8 different directions sequentially, will be recorded. In both devices, there will be a 1-minute rest break between measurements and they will be performed 3 times. The participant's limits of stability will be assessed with limits of stability test.

  Change from baseline to 7 day

• Sensory Integration Test

  The test decides which of the visual, vestibular, and proprioceptive information is used to provide orientation to maintain balance in different situations. During the test, visual and proprioceptive stimuli are disrupted and the ability to maintain the center of gravity is evaluated. The test consists of 4 different situations that gradually become more difficult: Situation 1: Eyes open; firm surface Situation 2: Eyes closed; firm surface Situation 3: Eyes open; foam surface Situation 4: Eyes closed; foam surface All measurements will be made with bare feet, and without shoes, and foot position will be recorded using coordinates on the platform's grid to ensure consistency in testing. The participant will be asked to stand still looking at the screen in front of him for 30 seconds. In both devices, there will be a 1-minute rest break between measurements and they will be performed 3 times. The participant's sensory integration will be assessed with Sensory Integration Test.

  Change from baseline to 7 day

• Bilateral Comparison Test

  Bilateral Comparison test demonstrates postural stability by measuring the individual's ability to stand on one leg with eyes open and closed. On the balance platform, the individual stands on one leg with his hands at hip level. The test is repeated for the right foot and left foot. For both feet, 3 trials with eyes open and 3 trials with eyes closed are made. Each trial lasts 30 seconds. What is required from the individual is to remain stable on one leg as much as possible without losing balance. All measurements will be made with bare feet, and without shoes, and foot position will be recorded using coordinates on the platform's grid to ensure consistency in testing. In both devices, there will be a 1-minute rest break between measurements and they will be performed 3 times. The participant's bilateral comparison will be assessed with Bilateral Comparison Test.

  Change from baseline to 7 day

• Multimodal Functional Reach Test

  Multimodal functional reaching test is performed in three different positions: front, back, and side. In the functional forward reach test, the patient stands with the arm flexed at 90° and the fist closed, not touching but close to the wall. Three attempts are made and the average of these attempts is taken. In the functional back reach test, the patient stands with the arm flexed at 90° and the fist closed, not touching but close to the wall. Three attempts are made and the average of these attempts is taken. In the functional lateral reach test, the patient stands with his back to the wall, without touching the wall, keeping his arm in 90° abduction and his fist closed. Three attempts are made and the average of these attempts is taken. Multimodal Functional Reach Test will performed as parallel clinical tests and the participant's Multimodal Functional Reach will be assessed with Multimodal Functional Reach Test.

  Change from baseline to 7 day

• One Leg Stance Test

  The one-leg stance test demonstrates postural stability by measuring the individual's ability to stand on one leg with eyes open and closed. The individual stands on one leg with his hands at hip level. The test is repeated for the right foot and left foot. For both feet, 3 trials with eyes open and 3 trials with eyes closed are made. Each trial lasts 30 seconds. What is required from the individual is to remain stable on one leg as much as possible without losing balance. One Leg Stance Test will performed as parallel clinical tests and the participant's One Leg Stance will be assessed with One Leg Stance Test.

  Change from baseline to 7 day

Study Arms (1)

Validity and Reliability

Participants will be evaluated with the "Postural Stability Test", "Limits of Stability Test", "Sensory Integration Test" and "Bilateral Comparison Test" within the AlBalance and Biodex Balance Evaluation System. To calculate the test-retest reliability and validity of the devices, these measurements will be made by the same evaluator in two sessions, 7 days apart. To eliminate the learning effect, participants who try AlBalance first in the first session will be the first to try Biodex in the second session (reverse test order will be used). Participants who complete all evaluations with the first device will rest for 5 minutes and move on to the other device. Then, parallel clinical tests will be applied to the participants, "Functional Reaching Test" and "One Leg Standing Test". The relationship of outcome measurements between devices and measurements of each test will be evaluated with statistical methods.

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy young adult between the ages of 18-25 who meet the inclusion criteria will be included in our study.

You may qualify if:

• Being between the ages of 18-25
• Body mass index is below 24
• They should be able to understand and follow instructions
• Volunteering to participate in the study

You may not qualify if:

• Presence of neuromuscular, rheumatic disease or vestibular problems that may affect balance
• Having a visual impairment that affects vision
• Any other exercise or physical activity that may affect trunk muscle strength or balance
• Having a recent history of orthopedic injury or surgery in the lower extremity
• Having experienced any acute situation that could affect postural stability and balance between the two tests (within 7 days)

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Officials

• Asena Yekdaneh

  Fenerbahçe University

  PRINCIPAL INVESTIGATOR

• İrem Kurt Ulusoy

  Istanbul University-Cerrahpasa, Institute of Postgraduate Education

  PRINCIPAL INVESTIGATOR

• Elçin Akyürek

  Istanbul University-Cerrahpasa, Institute of Postgraduate Education

  PRINCIPAL INVESTIGATOR

• Nilay Arman

  Istanbul University-Cerrahpaşa Faculty of Health Sciences

  STUDY CHAIR

• Ayşe Zengin Alpözgen

  Istanbul University-Cerrahpaşa Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

• Bülent Bayraktar

  Istanbul Faculty of Medicine, Department of Internal Medical Sciences, Department of Sports Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elcin Akyurek

CONTACT

+905077403731; oskanelcin@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: February 15, 2024
• Primary Completion: April 30, 2024
• Study Completion: May 30, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01