NCT04389255

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
Last Updated

May 15, 2020

Status Verified

March 1, 2019

Enrollment Period

2 months

First QC Date

May 12, 2020

Last Update Submit

May 12, 2020

Conditions

Keywords

balanceevaluationİnertial Measurement Unitvalidity and reliability

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Star Excursion Balance Test

    Day 0

  • Balance Master device

    Day 0

Study Arms (1)

Healthy people

65 people will be included.

Other: Star Excursion Balance TestDevice: Balance Master device

Interventions

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.\[

Healthy people

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.

Healthy people

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

65 healthy people, between 18 - 25 years of age

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University, Faculty of Health Sciences

Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

  • Cofre Lizama LE, Pijnappels M, Faber GH, Reeves PN, Verschueren SM, van Dieen JH. Age effects on mediolateral balance control. PLoS One. 2014 Oct 28;9(10):e110757. doi: 10.1371/journal.pone.0110757. eCollection 2014.

    PMID: 25350846BACKGROUND
  • Corriveau H, Hebert R, Raiche M, Prince F. Evaluation of postural stability in the elderly with stroke. Arch Phys Med Rehabil. 2004 Jul;85(7):1095-101. doi: 10.1016/j.apmr.2003.09.023.

    PMID: 15241756BACKGROUND
  • 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. doi: 10.1159/000093652.

    PMID: 16849863BACKGROUND
  • 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.

    PMID: 29410573BACKGROUND
  • Ericksen H, Gribble PA. Sex differences, hormone fluctuations, ankle stability, and dynamic postural control. J Athl Train. 2012 Mar-Apr;47(2):143-8. doi: 10.4085/1062-6050-47.2.143.

    PMID: 22488279BACKGROUND
  • 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.

    PMID: 26514832BACKGROUND
  • 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.

    PMID: 28746661BACKGROUND

Study Officials

  • İlksan Demirbuken, Assoc Prof

    Marmara University Health Science Faculty Physiotherapy amd Rehabilitation

    STUDY CHAIR
  • Zubeyir Sari, Assoc Prof

    Marmara University Health Science Faculty Physiotherapy amd Rehabilitation

    STUDY DIRECTOR
  • Ali Omer Acar, Inst

    Istanbul Aydin University Vocational School of Health Services Physiotherapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 15, 2020

Study Start

March 1, 2019

Primary Completion

May 1, 2019

Study Completion

June 27, 2019

Last Updated

May 15, 2020

Record last verified: 2019-03

Locations