Back to resultsValidity of Korebalance Balance System
Primary Purpose
Osteoporosis, Postmenopausal, Balance; Distorted
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Berg Balance Scale
Timed Up and Go Test
Korebalance Balance System
Sponsored by
About this trial
This is an interventional diagnostic trial for Osteoporosis, Postmenopausal focused on measuring osteoporosis, balance, berg balance scale, korebalance balance system
Eligibility Criteria
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.
Sites / Locations
- Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation DepartmentRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
postmenopausal osteoporosis
Arm Description
Postmenopausal osteoporotic patients evaluated with Berg Balance Scale, Timed Up and Go test and Korebalance balance system for balance disorder.
Outcomes
Primary Outcome Measures
Evaluate validity of Korebalance Balance System in postmenopausal osteoporotic patients
The statistical correlation of Korebalance Balance System and Berg Balance Scale was investigated.
Secondary Outcome Measures
Full Information
NCT ID
NCT03832075
First Posted
February 2, 2019
Last Updated
February 4, 2019
Sponsor
Istanbul Medeniyet University
1. Study Identification
Unique Protocol Identification Number
NCT03832075
Brief Title
Validity of Korebalance Balance System
Official Title
Validity of Korebalance Balance System in Postmenopausal Osteoporotic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
February 28, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal, Balance; Distorted
Keywords
osteoporosis, balance, berg balance scale, korebalance balance system
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
postmenopausal osteoporosis
Arm Type
Experimental
Arm Description
Postmenopausal osteoporotic patients evaluated with Berg Balance Scale, Timed Up and Go test and Korebalance balance system for balance disorder.
Intervention Type
Diagnostic Test
Intervention Name(s)
Berg Balance Scale
Intervention Description
Berg Balance Scale is 14 item scale for detecting balance disorder.
Intervention Type
Diagnostic Test
Intervention Name(s)
Timed Up and Go Test
Intervention Description
Timed Up and Go Test assesses mobility, balance, walking ability, and fall risk in older adults.
Intervention Type
Diagnostic Test
Intervention Name(s)
Korebalance Balance System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate validity of Korebalance Balance System in postmenopausal osteoporotic patients
Description
The statistical correlation of Korebalance Balance System and Berg Balance Scale was investigated.
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postmenopausal osteoporotic patients
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department
City
Istanbul
ZIP/Postal Code
34732
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bilinç Doğruöz Karatekin
Phone
+905368308709
Email
bilincdogruoz@hotmail.com
First Name & Middle Initial & Last Name & Degree
Bilinç Doğruöz Karatekin, MD
First Name & Middle Initial & Last Name & Degree
Afitap İçağasıoğlu, MD, Prof
First Name & Middle Initial & Last Name & Degree
Yasemin Yumuşakhuylu, MD, Ass. Prof
First Name & Middle Initial & Last Name & Degree
Fethullah Bayram, MD
First Name & Middle Initial & Last Name & Degree
Şeyhmus Yaşin, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Validity of Korebalance Balance System
We'll reach out to this number within 24 hrs