Clinical trial NCT04389255: Developing a Balance Assessment System
Official title: Developing a Balance Assessment System With Inertial Sensors and Investigating Validity and Reliability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy People
Assessment
Keywords: balance
evaluation
İnertial Measurement Unit
validity and reliability
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 65 healthy people, between 18 - 25 years of age

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Newly Developed Balance Assessment System
timeFrame: Day 0
measure: Newly Developed Balance Assessment System
timeFrame: Day 7
Secondary outcomes:
measure: Star Excursion Balance Test
timeFrame: Day 0
measure: Balance Master device
timeFrame: Day 0
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University, Faculty of Health Sciences
Study officials:
affiliation: Marmara University Health Science Faculty Physiotherapy amd Rehabilitation
name: İlksan Demirbuken, Assoc Prof
role: STUDY_CHAIR
affiliation: Marmara University Health Science Faculty Physiotherapy amd Rehabilitation
name: Zubeyir Sari, Assoc Prof
role: STUDY_DIRECTOR
affiliation: Istanbul Aydin University Vocational School of Health Services Physiotherapy
name: Ali Omer Acar, Inst
role: PRINCIPAL_INVESTIGATOR
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