Developing a Balance Assessment System

Healthy People Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04389255
• Other study ID #: 09.2019.274
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: June 27, 2019

Study information

• Verified date: March 2019
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 27, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Assessment
• Healthy People

Intervention

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.

Locations

Country	Name	City	State
Turkey	Marmara University, Faculty of Health Sciences	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Cofré Lizama LE, Pijnappels M, Faber GH, Reeves PN, Verschueren SM, van Dieën JH. Age effects on mediolateral balance control. PLoS One. 2014 Oct 28;9(10):e110757. doi: 10.1371/journal.pone.0110757. eCollection 2014. Erratum in: PLoS One. 2015;10(2):e0118012. — View Citation

Corriveau H, Hébert R, Raîche M, Prince F. Evaluation of postural stability in the elderly with stroke. Arch Phys Med Rehabil. 2004 Jul;85(7):1095-101. — View Citation

Era P, Sainio P, Koskinen S, Haavisto P, Vaara M, Aromaa A. Postural balance in a random sample of 7,979 subjects aged 30 years and over. Gerontology. 2006;52(4):204-13. — View Citation

Ericksen H, Gribble PA. Sex differences, hormone fluctuations, ankle stability, and dynamic postural control. J Athl Train. 2012 Mar-Apr;47(2):143-8. — View Citation

Glave AP, Didier JJ, Weatherwax J, Browning SJ, Fiaud V. Testing Postural Stability: Are the Star Excursion Balance Test and Biodex Balance System Limits of Stability Tests Consistent? Gait Posture. 2016 Jan;43:225-7. doi: 10.1016/j.gaitpost.2015.09.028. Epub 2015 Oct 26. — View Citation

Nakagawa HB, Ferraresi JR, Prata MG, Scheicher ME. Postural balance and functional independence of elderly people according to gender and age: cross-sectional study. Sao Paulo Med J. 2017 May-Jun;135(3):260-265. doi: 10.1590/1516-3180.2016.0325280217. — View Citation

Suzuki Y, Yatoh S, Suzuki H, Tanabe Y, Shimizu Y, Hada Y, Shimano H. Age-dependent changes in dynamic standing-balance ability evaluated quantitatively using a stabilometer. J Phys Ther Sci. 2018 Jan;30(1):86-91. doi: 10.1589/jpts.30.86. Epub 2018 Jan 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Newly Developed Balance Assessment System	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
Primary	Newly Developed Balance Assessment System	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	Star Excursion Balance Test	The Star Excursion Balance Test (SEBT) is a dynamic test that requires strength, flexibility, and proprioception.	Day 0
Secondary	Balance Master device	The Balance Master (Neurocom International, Inc Clackamas,) device is a computerized posturography device.	Day 0