NCT06756997

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

January 10, 2025

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2025

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

February 3, 2025

Status Verified

December 1, 2024

Enrollment Period

15 days

First QC Date

December 24, 2024

Last Update Submit

January 31, 2025

Conditions

Keywords

balance assessmentsensory condition

Outcome Measures

Primary Outcomes (2)

  • 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.

    "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.

    "From January 2025 to February 2025

Study Arms (1)

Study Group

Healthy Young Adults

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Istanbul, 34050, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Dr.

Study Record Dates

First Submitted

December 24, 2024

First Posted

January 3, 2025

Study Start

January 10, 2025

Primary Completion

January 25, 2025

Study Completion

January 31, 2025

Last Updated

February 3, 2025

Record last verified: 2024-12

Locations