- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04660357
Osteoarthritis, Balance, and Fear of Falling (OA)
December 8, 2020 updated by: Özgü İnal, Hacettepe University
Do Activity-Specific Balance Confidence and Fear of Fall Affect Autonomy and Social Participation in Individuals With Knee Osteoarthritis Above 65 Years Old?
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.
Study Overview
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.
Study Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Merkez
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Edirne, Merkez, Turkey
- Özgü İnal
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 90 years (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
- 65 years old
- Diagnosed with knee osteoarthritis according to ACR diagnostic criteria
Description
Inclusion Criteria:
- 65 years old
- Diagnosed with knee osteoarthritis according to ACR diagnostic criteria
Exclusion Criteria:
Not having enough cooperation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: 1 year
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 20, 2020
Primary Completion (ANTICIPATED)
September 20, 2021
Study Completion (ANTICIPATED)
September 20, 2021
Study Registration Dates
First Submitted
December 2, 2020
First Submitted That Met QC Criteria
December 8, 2020
First Posted (ACTUAL)
December 9, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 9, 2020
Last Update Submitted That Met QC Criteria
December 8, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/281
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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