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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03832075
Other study ID # MedeniyetOP2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2018
Est. completion date February 28, 2019

Study information

Verified date February 2019
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In postmenopausal osteoporosis patients, the balance is impaired. Equilibrium is evaluated with various test and balance systems. This study aims evaluation of the patients with the Korebalance Balance System and balance tests and investigation the validity of the Korebalance Balance System.


Description:

53 postmenopausal osteoporosis patients were evaluated with balance tests (Berg Balance Scale (BBS) and Timed Up and Go Test (TUG)) and Korebalance Balance System. The Korebalance Balance System is a balance assessment and exercise system. The higher the score, the greater the deterioration in the balance. The results of static and dynamic balance evaluation are recorded as score values. In this study, investigators compared Korebalance Balance System, Berg Balance Scale (BBS) and Timed Up and Go (TUG) tests and other demographic and clinical parameters (age, body mass index (BMI), 25OHvitD level, menopause age, fall within the last 1 year, fracture history, history of fracture in mother).


Recruitment information / eligibility

Status Recruiting
Enrollment 53
Est. completion date February 28, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers No
Gender Female
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Having postmenopausal osteoporosis

- No other disease that can cause balance disorder

- Volunteer participation in the study

Exclusion Criteria:

- To have a disease that will cause balance disorder,

- Having understanding problem to prevent communication with the patient,

- The lack of motor function to the balance device.

Study Design


Intervention

Diagnostic Test:
Berg Balance Scale
Berg Balance Scale is 14 item scale for detecting balance disorder.
Timed Up and Go Test
Timed Up and Go Test assesses mobility, balance, walking ability, and fall risk in older adults.
Korebalance Balance System
Korebalance Balance System evaluates the balance and stability using objective neuro-sensory balance assessment. Static Test requires standing steady & balancing on the platform, keeping the crosshairs of cursor in the center of the test pattern. The Score indicates the deviation of user's center of gravity from the center of the pattern. Dynamic Test offers a moving cursor that the user "follows". Four patterns are offered: Circle, Square, Infinity and Random. Each pattern is available in three dimensions: Small, Medium and Large; five speeds; Clockwise and Counterclockwise directions.

Locations

Country Name City State
Turkey Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate validity of Korebalance Balance System in postmenopausal osteoporotic patients The statistical correlation of Korebalance Balance System and Berg Balance Scale was investigated. 6 months
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