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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03884088
Other study ID # GO 19/29
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date August 1, 2021

Study information

Verified date March 2022
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There is many subjective balance tests to evaluate static and dynamic balance. But, there is no sufficient information about which balance test is the most sensitive test to evaluate balance. Therefore, the aim of this study is to compare of sensitivity of the subjective balance tests with an objective system.


Description:

In the clinical setting, many balance tests are used for evaluating balance in individuals. These tests are utilized to assess both static and dynamic balance. However, sufficient research has not been conducted to decide which subjective balance test is more sensitive than the other tests. Therefore, the aim of this study is to compare of sensitivity of the subjective balance tests with an objective system.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date August 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - at least 18 years, - To be a volunteer to participate Exclusion Criteria: - orthopedic problems affecting gait and stance - visual, auditory, orientational problems that could affect study results, - Walking with assist device - Having a neurological disorders

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Limits of Stability
Balance analysis is assessment method to estimate fall of risk and deterioration of postural control.

Locations

Country Name City State
Turkey Ozden Ozkal Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Limits of Stability Limits of stability test evaluates dynamic balance of participants. Computerized balance system measured limits of stability for forward, backward, right and left side movements. It calculates the maximum distance a person can lean without losing balance. The unit of measure is centimeters. The higher value is indicated the better balance 15 minutes
Primary Postural Sway Postural sway in centimeters by computerized balance system 15 minutes
Secondary Timed up and go test Timed up and go test evaluates dynamic balance of participants. The timed up and go test measures the time that a patient needs to stand up from a chair, walk a 3-m distance, come back and sit back on the chair.Timed up and go test measure is second. The lower values indicates the better balance 15 minutes
Secondary Functional reach test Functional reach test evaluates dynamic balance by measuring the limits while the patient reaches forwards as far as possible. The test measure is centimeters. A higher score indicates better dynamic balance. 15 minutes
Secondary One-leg stance test One-leg stance test evaluates static balance of the participants. Participants would ask to maintain their static balance by standing one-lag stance. The test measure is second. A higher score indicated better static balance 15 minutes
Secondary Romberg test Romberg test is used to evaluate static balance. Participants would ask to maintain their balance with their feet together (touching each other). The test measure is second. Higher score indicated better balance. 15 minutes
Secondary Berg balance scale Berg balance scale is used for functional balance. participants are asked to perform 14 tasks frequently used in daily life activities. The highest possible score is 56 points. A higher score indicates better balance. 15 minutes
Secondary Balance scale Balance scale which is developed by Tinetti is used to evaluate functional balance. This test has a gait score and a balance score. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the scale, the higher the risk of falling. 15 minutes
Secondary Y balance test Y balance test is used to evaluate dynamic balance. The Y balance test has the patient stand on one leg while reaching out in 3 different directions with the other lower extremity. They are anterior, posteromedial and posterolateral. The test measures in centimeters. The higher score indicates better balance 15 minutes
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