Osteoarthritis, Balance, and Fear of Falling | NCT04660357

Studies
Osteoarthritis, Balance, and Fear of Falling

NCT04660357

Sponsor

Hacettepe University

Status

Unknown status

Last Update Posted

Dec 9, 2020Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Osteoarthritis

Interventions

survey study

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2020Actual

Primary Completion Date

Sep 20, 2021Estimated

Completion Date

Sep 20, 2021Estimated

First Submitted Date

Dec 2, 2020

First Submission Date that Met QC Criteria

Dec 8, 2020

First Posted Date

Dec 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2020

Last Update Posted Date

Dec 9, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Özgü İnal, principal investigator, Hacettepe UniversityPrincipal Investigator

Lead Sponsor

Hacettepe UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Osteoarthritis (OA) is a progressive and irreversible degenerative joint disease characterized by marginal bone hypertrophy, erosion, and subchondral sclerosis in the articular cartilage.It has been determined that being of advanced age and joint involvement due to osteoarthritis are a risk factor for addiction in activities and this increases the individual's self-care ability and dependency in daily living activities.Older individuals with knee osteoarthritis may be at risk of falling.This study was planned to examine the relationship between activity-specific balance confidence and fear of falling, autonomy and social participation in individuals with knee osteoarthritis over 65 years of age.

Detailed Description

Osteoarthritis (OA) is a progressive and irreversible degenerative joint disease characterized by marginal bone hypertrophy, erosion, and subchondral sclerosis in the articular cartilage.It has been determined that being of advanced age and joint involvement due to osteoarthritis are a risk factor for addiction in activities and this increases the individual's self-care ability and dependency in daily living activities.Older individuals with knee osteoarthritis may be at risk of falling.Considering the relationship between the concepts of osteoarthritis and old age with the common concepts of daily life activity problems, falling, loss of autonomy and affecting social participation; this study was planned to examine the relationship between activity-specific balance confidence and fear of falling, autonomy and social participation in individuals with knee osteoarthritis over 65 years of age.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
survey study	Other	survey study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
WOMAC, The Activities-specific Balance Confidence Scale, Falls Efficacy Scale, The functional autonomy measurement system, Community Integration Questionnaire, Berg Balance Scale	The WOMAC index is a disease-specific, self-administered questionnaire developed to study patients with hip or knee OA. It consists of 24 questions, grouped into 3 subscales.Higher scores indicate more or worse symptoms, maximal limitations, and poor health.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

65 years old
Diagnosed with knee osteoarthritis according to ACR diagnostic criteria

Exclusion Criteria:

Not having enough cooperation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

90 Years

Standard Ages

Older Adult

Study Population

65 years old
Diagnosed with knee osteoarthritis according to ACR diagnostic criteria

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Özgü İnal	Trakya University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Özgü İnal		Edirne	Merkez		Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008137	Longitudinal Studies

Ancestor Terms

ID	Term
D015331	Cohort Studies
D016021	Epidemiologic Studies
D016020	Epidemiologic Study Characteristics
D004812	Epidemiologic Methods

Browse Leaves

Not provided

Browse Branches

Not provided