HealthyNCT06224374
Validity and Reliability of the Newly Developed Balance Assessment System in Healthy Young Adults
An observational study of Healthy and Assessment, Self, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Assessment, Self
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 30 Nov 2024
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy young adult between the ages of 18-25 who meet the inclusion criteria will be included in our study.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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".
Read the detailed description
Balance refers to the ability to maintain the center of gravity within the base of support, regardless of age, and is the foundation of movement. Postural stability is defined as the ability to control the body's center of mass on the base of support and maintain an upright posture. Postural stability is a complex skill that relies on the interaction of multiple dynamic sensorimotor and cognitive systems under static and dynamic conditions. Postural stability and balance are two of the most important factors that determine a person's ability to make and maintain movements Conducting balance and postural stability research is of great importance for both diagnosis and treatment purposes. Commonly used tests such as the Berg Balance Test and Functional Reaching Test can detect changes in balance and postural stability, but the accuracy of the tests is limited as they are highly dependent on the tester's abilities and familiarity with the scale. Therefore, in addition to clinical evaluations, various commercial testing devices are also used to provide needed information about balance and postural stability. Our study aims to evaluate the validity and reliability of the "Postural Stability Test", "Limits of Stability Test", "Sensory Integration Test" and "Bilateral Comparison Test" tests of the newly developed patented balance assessment system in healthy young adults.
With this study, the reliability of a new and local balance assessment system will be tested in healthy young adults. We think that this study will provide preliminary information about the use of a new and local device for professionals working in the field of postural stability and balance assessment.
- Conditions
- Healthy, Assessment, Self
- Keywords
- young adult, healthy, balance, validity, assessment
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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start15 Jun 2024
- Primary completion30 Jul 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elcin Akyurek, Istanbul University - Cerrahpasa
- Investigators
- Asena Yekdaneh, Principal investigator, Fenerbahçe Universityİrem Kurt Ulusoy, Principal investigator, Istanbul University-Cerrahpasa, Institute of Postgraduate EducationElçin Akyürek, Principal investigator, Istanbul University-Cerrahpasa, Institute of Postgraduate EducationNilay Arman, Study chair, Istanbul University-Cerrahpaşa Faculty of Health SciencesAyşe Zengin Alpözgen, Principal investigator, Istanbul University-Cerrahpaşa Faculty of Health SciencesBülent Bayraktar, Principal investigator, Istanbul Faculty of Medicine, Department of Internal Medical Sciences, Department of Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224374
- Sponsor's protocol ID
- AkyurekE3
- Status last verified
- May 2026
- First submitted
- 16 Jan 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Newly Developed Balance Assessment System in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT06224374
- Acronym / sponsor ID
- AkyurekE3
- Conditions
- Healthy, Assessment, Self
- Keywords
- young adult, healthy, balance, validity, assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 25 Jan 2024 (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.
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".
Detailed description
Balance refers to the ability to maintain the center of gravity within the base of support, regardless of age, and is the foundation of movement. Postural stability is defined as the ability to control the body's center of mass on the base of support and maintain an upright posture. Postural stability is a complex skill that relies on the interaction of multiple dynamic sensorimotor and cognitive systems under static and dynamic conditions. Postural stability and balance are two of the most important factors that determine a person's ability to make and maintain movements Conducting balance and postural stability research is of great importance for both diagnosis and treatment purposes. Commonly used tests such as the Berg Balance Test and Functional Reaching Test can detect changes in balance and postural stability, but the accuracy of the tests is limited as they are highly dependent on the tester's abilities and familiarity with the scale. Therefore, in addition to clinical evaluations, various commercial testing devices are also used to provide needed information about balance and postural stability. Our study aims to evaluate the validity and reliability of the "Postural Stability Test", "Limits of Stability Test", "Sensory Integration Test" and "Bilateral Comparison Test" tests of the newly developed patented balance assessment system in healthy young adults.
With this study, the reliability of a new and local balance assessment system will be tested in healthy young adults. We think that this study will provide preliminary information about the use of a new and local device for professionals working in the field of postural stability and balance assessment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy young adult between the ages of 18-25 who meet the inclusion criteria will be included in our study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
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
Postural Stability Test
Time frame: Change from baseline to 7 day
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.
Limits of Stability
Time frame: Change from baseline to 7 day
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.
Sensory Integration Test
Time frame: Change from baseline to 7 day
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.
Bilateral Comparison Test
Time frame: Change from baseline to 7 day
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.
Multimodal Functional Reach Test
Time frame: Change from baseline to 7 day
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.
One Leg Stance Test
Time frame: Change from baseline to 7 day
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.
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 18 May 2026.
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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.
Asena Yekdaneh principal investigator
Fenerbahçe University
İrem Kurt Ulusoy principal investigator
Istanbul University-Cerrahpasa, Institute of Postgraduate Education
Elçin Akyürek principal investigator
Istanbul University-Cerrahpasa, Institute of Postgraduate Education
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 Healthy and Assessment, Self, run by Istanbul University - Cerrahpasa 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 4 inclusion and 5 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 18 May 2026. 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?
Postural Stability Test (time frame: Change from baseline to 7 day). 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 18 May 2026.