Developing a Balance Assessment System

May 12, 2020 updated by: Marmara University

Developing a Balance Assessment System With Inertial Sensors and Investigating Validity and Reliability

To develop a balance device that will work with the inertia sensor to quantitatively assess the balance of individuals and investigate the validity and reliability of the balance data of the device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, we aim to develop a balance assessment system that will measure the balance quantitatively. For this balance assessment system, a balance board will be developed that will work with inertial sensors and detect the oscillations of the individual trying to stand on balance. The validity and reliability of the balance score determined by the analysis of the oscillation data of this balance board will be investigated.

Our hypothesis is that the correlation between the balance score revealed by the newly developed evaluation system and the results of clinical and instrumental balance assessment methods will be significant. For this, one commonly used clinic and one instrumental balance assessment method will be used. Star Excursion Balance Test as a clinical balance assessment method and Balance Master device (BMc) as an instrumental balance assessment method were evaluated. Limits of Stability Test (LOS) and Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) were used in the BMc.

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

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

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Marmara University, Faculty of Health Sciences

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

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

65 healthy people, between 18 - 25 years of age

Description

Inclusion Criteria:

  • Age between 18 - 25
  • No neurological or orthopedic diagnosis to affect balance
  • Lack of vision and hearing defects that will affect the tests

Exclusion Criteria:

  • Existence of refraction problem, visual problem
  • Failure to complete the specified tests
  • Participant's failure to comply with the study plan

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy people
65 people will be included.
Other: Star Excursion Balance Test
The Star Excursion Balance Test (SEBT) is a dynamic test that requires strength, flexibility, and proprioception. It is a measure of dynamic balance that provides a significant challenge to athletes and physically active individuals. The test can be used to assess physical performance, but can also be used to screen deficits in dynamic postural control due to musculoskeletal injuries (e.g. chronic ankle instability), to identify athletes at greater risk for lower extremity injury, as well as during the rehabilitation of orthopeadic injuries in healthy active adults.[
Device: Balance Master device
The Balance Master (Neurocom International, Inc Clackamas,) device is a computerized posturography device. The device consists of a fixed support surface consisting of a force table and individuals, a variety of ground elements and a computer screen that will provide visual feedback and conduct test protocols. Posturography tests a person's ability to integrate visual, vestibular and somatosensory inputs and suppress inappropriate sensory information. Thus, it can quantitatively score the person's balance and examine balance problems in detail with the tests it contains. There are various protocols that evaluate balance differently in Balance Master (BMc). Limits of Stability Test (LOS) and Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) were used in the BMc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Newly Developed Balance Assessment System
Time Frame: Day 0
The newly developed balance evaluation system includes an Arduino based circuit board and an inertial measurement unit consisting of a combination of 3-axis accelerometer and 3-axis gyroscope.
Day 0
Newly Developed Balance Assessment System
Time Frame: Day 7
The newly developed balance evaluation system includes an Arduino based circuit board and an inertial measurement unit consisting of a combination of 3-axis accelerometer and 3-axis gyroscope.
Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Star Excursion Balance Test
Time Frame: Day 0
The Star Excursion Balance Test (SEBT) is a dynamic test that requires strength, flexibility, and proprioception.
Day 0
Balance Master device
Time Frame: Day 0
The Balance Master (Neurocom International, Inc Clackamas,) device is a computerized posturography device.
Day 0

Collaborators and Investigators

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

Sponsor

Marmara University

Investigators

  • Study Chair: İlksan Demirbuken, Assoc Prof, Marmara University Health Science Faculty Physiotherapy amd Rehabilitation
  • Study Director: Zubeyir Sari, Assoc Prof, Marmara University Health Science Faculty Physiotherapy amd Rehabilitation
  • Principal Investigator: Ali Omer Acar, Inst, Istanbul Aydin University Vocational School of Health Services Physiotherapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2019

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

June 27, 2019

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 15, 2020

Study Record Updates

Last Update Posted (Actual)

May 15, 2020

Last Update Submitted That Met QC Criteria

May 12, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 09.2019.274

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

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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