The Effect of Different Sensory Conditions on Sensory Interaction in Balance

January 31, 2025 updated by: Deniz Tuncer, Bezmialem Vakif University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34050
        • Bezmialem Vakif University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Being between the ages of 18 and 45.
  • Providing informed consent to participate in the study after receiving detailed information about the research.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Study Group
Healthy Young Adults

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
"From January 2025 to February 2025
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.
"From January 2025 to February 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bezmialem Vakif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-54022451-050.04-173777

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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