OsteoarthritisOANCT04660357
Osteoarthritis, Balance, and Fear of Falling
An observational study of Osteoarthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- survey study
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2020to 20 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: * 65 years old * Diagnosed with knee osteoarthritis according to ACR diagnostic criteria
Who may be able to join
- 65 years old
- Diagnosed with knee osteoarthritis according to ACR diagnostic criteria
Who cannot join
- Not having enough cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- survey study
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey studyOther
survey study
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start20 Sep 2020
- Primary completion20 Sep 2021 (estimated)
- Study completion20 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgü İnal, Hacettepe University
- Investigators
- Özgü İnal, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660357
- Sponsor's protocol ID
- 2020/281
- Acronym
- OA
- Status last verified
- Aug 2020
- First submitted
- 2 Dec 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Activity-Specific Balance Confidence and Fear of Fall Affect Autonomy and Social Participation in Individuals With Knee Osteoarthritis Above 65 Years Old?
- ClinicalTrials.gov ID
- NCT04660357
- Acronym / sponsor ID
- OA / 2020/281
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 20 Sep 2021 (estimated)
- Study completion
- 20 Sep 2021 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- * 65 years old * Diagnosed with knee osteoarthritis according to ACR diagnostic criteria
Key inclusion criteria (2 listed)
- 65 years old
- Diagnosed with knee osteoarthritis according to ACR diagnostic criteria
Key exclusion criteria (1 listed)
- Not having enough cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| survey studysurvey study | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özgü İnal principal investigator
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.