Knee OsteoarthritisNCT05294224
The Relationship Between Disease Severity and Various Lower Extremity Parameters in Individuals With Knee Osteoarthritis
An observational study of Knee Osteoarthritis and Knee Injuries, run by Dilara Özen Oruk at 1 site in Turkey (Türkiye).
Trial summary
This study perform to investigate the relationship between quadriceps femoris (QF) strength, QF thickness, femoral cartilage thickness, knee function, balance, kinesiophobia and gait of the patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Knee Injuries
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Apr 2022to 30 Sep 2023
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Volunteer patients who applied to the Physical therapy and Rehabilitation department with knee pain
Who may be able to join
- Volunteer patients who applied to the Physical therapy and Rehabilitation department with knee pain
Who cannot join
- Individuals who have received intra-articular therapy for gonarthrosis in the last 6 months, who have undergone arthroscopic surgery, and who have additional pathologies in their lower extremities
- Individuals with physical, mental and/or psychological disorders that may affect participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
This study perform to investigate the relationship between quadriceps femoris (QF) strength, QF thickness, femoral cartilage thickness, knee function, balance, kinesiophobia and gait of the patients with knee osteoarthritis.
Read the detailed description
Osteoarthritis (OA) is one of the most common chronic degenerative diseases in the world, which progresses slowly, can cause pain, stiffness and dysfunction, and reduces the quality of life.
OA is particularly common in weight-bearing joints such as the knee and the functional status of patients with OA is adversely affected various factors such as immobility due to pain, decrease in muscle strength and joint range of motion, etc.
In relation to this, walking difficulty and decrease in walking speed, balance problems and an increase in the risk of falling are a picture that can be encountered in the later stages of the disease.
The aim of this study is to investigate the relationship between QF strength, QF thickness, femoral cartilage thickness, knee function, balance, kinesiophobia and gait of the patients with knee OA.
- Conditions
- Knee Osteoarthritis, Knee Injuries
- Keywords
- muscle thikness, cartilage thickness, balance, postural stability, kinesiophobia, gait, degeneration, function
- Medical subject headings
- Osteoarthritis, Knee, Knee Injuries, Kinesiophobia
What is being measured
The primary outcome is the main question the study is designed to answer.
QF muscle thickness
QF muscle thickness
Measured: Day 1
QF muscle strength
QF muscle strength
Measured: Day 1
Femoral cartilage thickness
Femoral cartilage thickness
Measured: Day 1
Knee function
Knee function assessment with The Knee injury and Osteoarthritis Outcome Score (KOOS). It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. The maximum score a patient can achieve is 100, indicating no knee problems. The minimum score is zero, indicating severe knee problems.
Measured: Day 1
Kellgreen-Lawrence Radiological Stages
Kellgreen-Lawrence Radiological Stages:
Grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping. grade 2 (minimal): definite osteophytes and possible joint space narrowing. grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends.
Measured: Day 1
Kinesiophobia
Tampa Kinesiophobia Scale: The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia.
Measured: Day 1
Balance and gait
Tinetti Score: It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the Tinetti test, the higher the risk of falling.
Measured: Day 1
Low Extremity Functionality and Fall Risk
30 sec sit to stand test
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start17 Apr 2022
- Primary completion30 Aug 2022
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilara Özen Oruk
- Sponsor type
- University, hospital or other
- Collaborators
- Muğla Sıtkı Koçman University
- Responsible party
- Sponsor-investigator, Dilara Özen Oruk, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294224
- Sponsor's protocol ID
- 210077/10
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Disease Severity and Various Lower Extremity Parameters in Individuals With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05294224
- Acronym / sponsor ID
- 210077/10
- Conditions
- Knee Osteoarthritis, Knee Injuries
- Keywords
- muscle thikness, cartilage thickness, balance, postural stability, kinesiophobia, gait, degeneration, function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dilara Özen OrukUniversity, hospital or other
- Collaborators
- Muğla Sıtkı Koçman University
- Study start
- 17 Apr 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 24 Mar 2022 (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.
This study perform to investigate the relationship between quadriceps femoris (QF) strength, QF thickness, femoral cartilage thickness, knee function, balance, kinesiophobia and gait of the patients with knee osteoarthritis.
Detailed description
Osteoarthritis (OA) is one of the most common chronic degenerative diseases in the world, which progresses slowly, can cause pain, stiffness and dysfunction, and reduces the quality of life.
OA is particularly common in weight-bearing joints such as the knee and the functional status of patients with OA is adversely affected various factors such as immobility due to pain, decrease in muscle strength and joint range of motion, etc.
In relation to this, walking difficulty and decrease in walking speed, balance problems and an increase in the risk of falling are a picture that can be encountered in the later stages of the disease.
The aim of this study is to investigate the relationship between QF strength, QF thickness, femoral cartilage thickness, knee function, balance, kinesiophobia and gait of the patients with knee OA.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteer patients who applied to the Physical therapy and Rehabilitation department with knee pain
Key inclusion criteria (1 listed)
- Volunteer patients who applied to the Physical therapy and Rehabilitation department with knee pain
Key exclusion criteria (2 listed)
- Individuals who have received intra-articular therapy for gonarthrosis in the last 6 months, who have undergone arthroscopic surgery, and who have additional pathologies in their lower extremities
- Individuals with physical, mental and/or psychological disorders that may affect participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
QF muscle thickness
Time frame: Day 1
QF muscle thickness
QF muscle strength
Time frame: Day 1
QF muscle strength
Femoral cartilage thickness
Time frame: Day 1
Femoral cartilage thickness
Knee function
Time frame: Day 1
Knee function assessment with The Knee injury and Osteoarthritis Outcome Score (KOOS). It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. The maximum score a patient can achieve is 100, indicating no knee problems. The minimum score is zero, indicating severe knee problems.
Kellgreen-Lawrence Radiological Stages
Time frame: Day 1
Kellgreen-Lawrence Radiological Stages: Grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping. grade 2 (minimal): definite osteophytes and possible joint space narrowing. grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends.
Kinesiophobia
Time frame: Day 1
Tampa Kinesiophobia Scale: The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia.
Balance and gait
Time frame: Day 1
Tinetti Score: It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the Tinetti test, the higher the risk of falling.
Low Extremity Functionality and Fall Risk
Time frame: Day 1
30 sec sit to stand test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Related trials for Knee Osteoarthritis
RecruitingPhase 3
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
Knee Cartilage Defects
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
RecruitingPhase 4
Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
Periarticular Block, Osteoarthritis (OA)
Not yet recruiting
Robotic-Assisted Versus Conventional Total Knee Arthroplasty With Virtual Home-Based Rehabilitation
Osteoarthritis, Knee
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Knee Osteoarthritis and Knee Injuries, run by Dilara Özen Oruk 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 15 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
QF muscle thickness (time frame: Day 1). The study lists 8 primary outcomes in all. 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 15 Mar 2024; AzTrials last refreshed its copy on 30 Oct 2026.