Balance AssessmentNCT06756997
The Effect of Different Sensory Conditions on Sensory Interaction in Balance
An observational study of Balance Assessment and Sensory Science, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The ability of humans to maintain spatial orientation and balance control relies on accurate and complete sensory information. This study aims to investigate the effects of different sensory conditions on the sway index (balance). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance Assessment, Sensory Science
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2025to 31 Jan 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The population of the study will consist of 23 volunteer healthy young adult subjects aged 18-45 years. All subjects will be evaluated and tested at Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation.
Who may be able to join
- Being between the ages of 18 and 45.
- Providing informed consent to participate in the study after receiving detailed information about the research.
Who cannot join
- Having visual or hearing impairments.
- Presence of musculoskeletal, neurological, or orthopaedic conditions (e.g., lower extremity alignment disorders, excessive anteversion, severe pes planus) that could affect the study results.
- Having mental or physical problems severe enough to impair communication.
- Participation in any rehabilitation program within the past six months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Istanbul, 34050
About this study
The ability of humans to maintain spatial orientation and balance control relies on accurate and complete sensory information. This study aims to investigate the effects of different sensory conditions on the sway index (balance). Adults with normal hearing, vision, and balance abilities will perform the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB), a test from the Biodex Balance System, under varying sensory conditions. The first sensory condition involves situations where the cursor indicating the individual's center of gravity on the device is either visible or hidden. The second condition examines whether the eyes-closed state during the test is achieved through voluntary eye closure or by external equipment (e.g., goggles or eye patches). The values obtained will allow comparisons of the effects of different sensory conditions on the sway index. The study will be conducted between January 2025 and March 2025 at the Bezmialem Vakıf University Cardiac Physiotherapy and Rehabilitation Education and Research Laboratory with healthy young adults. Participants will be selected voluntarily, and the assessments will be conducted in compliance with the guidelines of the Declaration of Helsinki.
- Conditions
- Balance Assessment, Sensory Science
- Keywords
- balance assessment, sensory condition
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 |
|---|---|---|
| Study Group | Healthy Young Adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
The assessment of postural control will be conducted using the Biodex Balance System® (BBS) (Biodex Medical Systems, Shirley, New York, USA). The BBS consists of a balance platform, handrails, a display, and a printer, it is a computer-assisted device with established validity and reliability, used to evaluate postural stability, limits of stability, and fall risk.
The device features a movable platform capable of providing surface tilts up to 20˚ and a 360˚ range of motion, allowing individuals to move forward, backwards, left, and right. By altering the platform's tilt and range of motion, the difficulty level of the test can be adjusted. Mobility levels range from 1 (minimum) to 12 (maximum).
This test evaluates how different sensory systems contribute to balance and assesses an individual's ability to compensate when one or more sensory inputs are compromised. The tests will be performed in the following sequence, and the sway index will be calculated for each test conducted.
Measured: "From January 2025 to February 2025
Assessment Form
The "Assessment Form" will be used to record the demographic and medical history information of the healthy adult participants included in the study. The assessment form includes demographic details such as name, surname, gender, age, occupation, dominant side, and educational level, as well as medical and family history and the BBS assessment form.
Measured: "From January 2025 to February 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start10 Jan 2025
- Primary completion25 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance AssessmentStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Tuncer, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756997
- Sponsor's protocol ID
- E-54022451-050.04-173777
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Sensory Conditions on Sensory Interaction in Balance
- ClinicalTrials.gov ID
- NCT06756997
- Acronym / sponsor ID
- E-54022451-050.04-173777
- Conditions
- Balance Assessment, Sensory Science
- Keywords
- balance assessment, sensory condition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 25 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 3 Jan 2025 (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 ability of humans to maintain spatial orientation and balance control relies on accurate and complete sensory information. This study aims to investigate the effects of different sensory conditions on the sway index (balance). Adults with normal hearing, vision, and balance abilities will perform the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB), a test from the Biodex Balance System, under varying sensory conditions. The first sensory condition involves situations where the cursor indicating the individual's center of gravity on the device is either visible or hidden. The second condition examines whether the eyes-closed state during the test is achieved through voluntary eye closure or by external equipment (e.g., goggles or eye patches). The values obtained will allow comparisons of the effects of different sensory conditions on the sway index. The study will be conducted between January 2025 and March 2025 at the Bezmialem Vakıf University Cardiac Physiotherapy and Rehabilitation Education and Research Laboratory with healthy young adults. Participants will be selected voluntarily, and the assessments will be conducted in compliance with the guidelines of the Declaration of Helsinki.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –Healthy Young Adults |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The population of the study will consist of 23 volunteer healthy young adult subjects aged 18-45 years. All subjects will be evaluated and tested at Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation.
Key inclusion criteria (2 listed)
- Being between the ages of 18 and 45.
- Providing informed consent to participate in the study after receiving detailed information about the research.
Key exclusion criteria (4 listed)
- Having visual or hearing impairments.
- Presence of musculoskeletal, neurological, or orthopaedic conditions (e.g., lower extremity alignment disorders, excessive anteversion, severe pes planus) that could affect the study results.
- Having mental or physical problems severe enough to impair communication.
- Participation in any rehabilitation program within the past six months.
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
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
Time frame: "From January 2025 to February 2025
The assessment of postural control will be conducted using the Biodex Balance System® (BBS) (Biodex Medical Systems, Shirley, New York, USA). The BBS consists of a balance platform, handrails, a display, and a printer, it is a computer-assisted device with established validity and reliability, used to evaluate postural stability, limits of stability, and fall risk. The device features a movable platform capable of providing surface tilts up to 20˚ and a 360˚ range of motion, allowing individuals to move forward, backwards, left, and right. By altering the platform's tilt and range of motion, the difficulty level of the test can be adjusted. Mobility levels range from 1 (minimum) to 12 (maximum). This test evaluates how different sensory systems contribute to balance and assesses an individual's ability to compensate when one or more sensory inputs are compromised. The tests will be performed in the following sequence, and the sway index will be calculated for each test conducted.
Assessment Form
Time frame: "From January 2025 to February 2025
The "Assessment Form" will be used to record the demographic and medical history information of the healthy adult participants included in the study. The assessment form includes demographic details such as name, surname, gender, age, occupation, dominant side, and educational level, as well as medical and family history and the BBS assessment form.
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 3 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Balance Assessment and Sensory Science, run by Bezmialem Vakif University 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 2 inclusion and 4 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 3 Feb 2025. 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?
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) (time frame: "From January 2025 to February 2025). The study lists 2 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 3 Feb 2025.