Healthy PeopleNCT04389255
Developing a Balance Assessment System
An observational study of Healthy People and Assessment, run by Marmara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy People, Assessment
- What is being tested?
- Star Excursion Balance Test and Balance Master device
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 27 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 65 healthy people, between 18 - 25 years of age
Who may be able to join
- Age between 18 - 25
- No neurological or orthopedic diagnosis to affect balance
- Lack of vision and hearing defects that will affect the tests
Who cannot join
- Existence of refraction problem, visual problem
- Failure to complete the specified tests
- Participant's failure to comply with the study plan
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University, Faculty of Health Sciences
Istanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy People, Assessment
- Being tested
- Star Excursion Balance Test, Balance Master device
- Keywords
- balance, evaluation, İnertial Measurement Unit, validity and reliability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Star Excursion Balance TestOther
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.[
Balance Master deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy people | 65 people will be included. Receives: Other: Star Excursion Balance Test; Device: Balance Master device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 7
Secondary outcomes (2)
Star Excursion Balance Test
The Star Excursion Balance Test (SEBT) is a dynamic test that requires strength, flexibility, and proprioception.
Measured: Day 0
Balance Master device
The Balance Master (Neurocom International, Inc Clackamas,) device is a computerized posturography device.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 Mar 2019
- Primary completion1 May 2019
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Healthy PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- İlksan Demirbuken, Assoc Prof, Study chair, Marmara University Health Science Faculty Physiotherapy amd RehabilitationZubeyir Sari, Assoc Prof, Study director, Marmara University Health Science Faculty Physiotherapy amd RehabilitationAli Omer Acar, Inst, Principal investigator, Istanbul Aydin University Vocational School of Health Services Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389255
- Sponsor's protocol ID
- 09.2019.274
- Status last verified
- Mar 2019
- First submitted
- 12 May 2020
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25350846Corriveau 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.
PubMed 15241756Era 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.
PubMed 16849863Suzuki 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.
PubMed 29410573Ericksen 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.
PubMed 22488279Glave 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.
PubMed 26514832Nakagawa 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.
PubMed 28746661
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Balance Assessment System With Inertial Sensors and Investigating Validity and Reliability
- ClinicalTrials.gov ID
- NCT04389255
- Acronym / sponsor ID
- 09.2019.274
- Conditions
- Healthy People, Assessment
- Keywords
- balance, evaluation, İnertial Measurement Unit, validity and reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy people | – | Other: Star Excursion Balance Test, Device: Balance Master device65 people will be included. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 65 healthy people, between 18 - 25 years of age
Key inclusion criteria (3 listed)
- Age between 18 - 25
- No neurological or orthopedic diagnosis to affect balance
- Lack of vision and hearing defects that will affect the tests
Key exclusion criteria (3 listed)
- Existence of refraction problem, visual problem
- Failure to complete the specified tests
- Participant's failure to comply with the study plan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Star Excursion Balance TestThe 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.[ | Other | Healthy people |
| Balance Master deviceThe 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. | Device | Healthy people |
Primary outcome
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.
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.
2 secondary outcomes
Star Excursion Balance Test
Time frame: Day 0
Balance Master device
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Background: PubMed 25350846Cofre 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.
- Background: PubMed 15241756Corriveau 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.
- Background: PubMed 16849863Era 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.
- Background: PubMed 29410573Suzuki 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.
- Background: PubMed 22488279Ericksen 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.
- Background: PubMed 26514832Glave 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.
- Background: PubMed 28746661Nakagawa 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İlksan Demirbuken, Assoc Prof study chair
Marmara University Health Science Faculty Physiotherapy amd Rehabilitation
Zubeyir Sari, Assoc Prof study director
Marmara University Health Science Faculty Physiotherapy amd Rehabilitation
Ali Omer Acar, Inst principal investigator
Istanbul Aydin University Vocational School of Health Services Physiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy People and Assessment, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newly Developed Balance Assessment System (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04389255, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.