NCT03832075

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

February 2, 2019

Last Update Submit

February 4, 2019

Conditions

Osteoporosis, PostmenopausalBalance; Distorted

Keywords

osteoporosisbalanceberg balance scalekorebalance balance system

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

postmenopausal osteoporosis

EXPERIMENTAL

Postmenopausal osteoporotic patients evaluated with Berg Balance Scale, Timed Up and Go test and Korebalance balance system for balance disorder.

Diagnostic Test: Berg Balance ScaleDiagnostic Test: Timed Up and Go TestDiagnostic Test: Korebalance Balance System

Interventions

Berg Balance ScaleDIAGNOSTIC_TEST

Berg Balance Scale is 14 item scale for detecting balance disorder.

postmenopausal osteoporosis
Timed Up and Go TestDIAGNOSTIC_TEST

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

postmenopausal osteoporosis
Korebalance Balance SystemDIAGNOSTIC_TEST

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.

postmenopausal osteoporosis

Eligibility Criteria

Age50 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostmenopausal osteoporotic patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having postmenopausal osteoporosis
  • No other disease that can cause balance disorder
  • Volunteer participation in the study

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department

Istanbul, 34732, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoporosis, PostmenopausalOsteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Research Assistant of PMR

Study Record Dates

First Submitted

February 2, 2019

First Posted

February 6, 2019

Study Start

August 1, 2018

Primary Completion

January 31, 2019

Study Completion

February 28, 2019

Last Updated

February 6, 2019

Record last verified: 2019-02

Locations

TU(1)