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Validity of Korebalance Balance System

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ClinicalTrials.gov Identifier: NCT03832075
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Bilinç Doğruöz Karatekin, Istanbul Medeniyet University

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.

Condition or disease Intervention/treatment Phase
Osteoporosis, Postmenopausal Balance; Distorted Diagnostic Test: Berg Balance Scale Diagnostic Test: Timed Up and Go Test Diagnostic Test: Korebalance Balance System Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validity of Korebalance Balance System in Postmenopausal Osteoporotic Patients
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : January 31, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Experimental: postmenopausal osteoporosis
Postmenopausal osteoporotic patients evaluated with Berg Balance Scale, Timed Up and Go test and Korebalance balance system for balance disorder.
Diagnostic Test: Berg Balance Scale
Berg Balance Scale is 14 item scale for detecting balance disorder.

Diagnostic Test: Timed Up and Go Test
Timed Up and Go Test assesses mobility, balance, walking ability, and fall risk in older adults.

Diagnostic Test: 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.




Primary Outcome Measures :
  1. Evaluate validity of Korebalance Balance System in postmenopausal osteoporotic patients [ Time Frame: 6 months ]
    The statistical correlation of Korebalance Balance System and Berg Balance Scale was investigated.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Postmenopausal osteoporotic patients
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832075


Locations
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Turkey
Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department Recruiting
Istanbul, Turkey, 34732
Contact: Bilinç Doğruöz Karatekin    +905368308709    bilincdogruoz@hotmail.com   
Principal Investigator: Bilinç Doğruöz Karatekin, MD         
Sub-Investigator: Afitap İçağasıoğlu, MD, Prof         
Sub-Investigator: Yasemin Yumuşakhuylu, MD, Ass. Prof         
Sub-Investigator: Fethullah Bayram, MD         
Sub-Investigator: Şeyhmus Yaşin, MD         
Sponsors and Collaborators
Istanbul Medeniyet University

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Responsible Party: Bilinç Doğruöz Karatekin, MD, Research Assistant of PMR, Istanbul Medeniyet University
ClinicalTrials.gov Identifier: NCT03832075     History of Changes
Other Study ID Numbers: MedeniyetOP2
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bilinç Doğruöz Karatekin, Istanbul Medeniyet University:
osteoporosis
balance
berg balance scale
korebalance balance system

Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases