Validity of Korebalance Balance System

Osteoporosis, Postmenopausal Clinical Trial

Official title:

Validity of Korebalance Balance System in Postmenopausal Osteoporotic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03832075
• Other study ID #: MedeniyetOP2
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Balance; Distorted
• Osteoporosis
• Osteoporosis, Postmenopausal

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