Knee Arthritis OsteoarthritisNCT07834827
Popliteus and Quadriceps Muscle Thickness and Clinical Parameters in Knee Osteoarthritis
An observational study of Knee Arthritis Osteoarthritis and Balance Assessment, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the relationships between the ultrasonographic muscle thicknesses of the popliteus and quadriceps muscles and functional capacity, balance, and pain levels in elderly patients with knee osteoarthritis (KOA). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Knee Arthritis Osteoarthritis, Balance Assessment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2026to 1 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Participants for this study will consist of individuals aged 65 years and older diagnosed with Grade 3 and Grade 4 knee osteoarthritis according to the Kellgren-Lawrence classification by a specialist physician, presenting to the Physical Medicine and Rehabilitation Outpatient Clinic of Afyonkarahisar Health Sciences University Health Application and Research Center. All evaluations within the scope of the study will be performed at the Physical Medicine and Rehabilitation Outpatient Clinic of Afyonkarahisar Health Sciences University Health Application and Research Center. Ultrasound (US) evaluations of the participants classified under Kellgren-Lawrence Grade 3 and Grade 4 will be performed.
Who may be able to join
- Individuals aged 65 years and older
- Individuals with a Standardized Mini-Mental State Examination (SMMSE) score of 24 and above
- Individuals classified as Grade 3-4 according to the Kellgren-Lawrence grading scale
Who cannot join
- Individuals under the age of 65
- Individuals with an SMMSE score below 24
- Individuals with central nervous system and visual pathologies that may affect balance
- Individuals with a history of lower extremity surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Science University
Merkez, Afyonkarahisar
About this study
Official title: The Relationship Between Popliteus and Quadriceps Muscle Thickness and Functional Capacity, Balance, and Pain in Elderly Patients With Knee Osteoarthritis
This study aims to examine the relationships between the ultrasonographic muscle thicknesses of the popliteus and quadriceps muscles and functional capacity, balance, and pain levels in elderly patients with knee osteoarthritis (KOA). Knee osteoarthritis is a major degenerative joint disorder causing pain, stiffness, and reduced mobility, where surrounding muscle architecture plays a pivotal role in functional performance and joint stability. The study will recruit approximately 150 participants aged 65 years and older with Grade 3-4 KOA (Kellgren-Lawrence) and intact cognitive status (SMMSE score ≥24) presenting to the Physical Medicine and Rehabilitation Outpatient Clinic of Afyonkarahisar Health Sciences University Health Application and Research Center, while excluding individuals with central nervous system, visual pathologies, or prior lower extremity surgeries. Muscle thicknesses of the popliteus and quadriceps (rectus femoris and vastus intermedius) will be measured via high-frequency B-mode ultrasonography by a specialist physician, using standardized anatomical landmarks and patient positioning. Functional capacity and mobility will be evaluated using the Timed Up and Go (TUG) and 5-Times Sit-to-Stand (5STS) tests, balance and proprioception via the Romberg Test, and knee-specific functional status and pain severity using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Visual Analog Scale (VAS).
- Conditions
- Knee Arthritis Osteoarthritis, Balance Assessment
- Keywords
- knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Knee OA Patients | Elderly patients diagnosed with knee osteoarthritis who meet the inclusion criteria. Popliteus and quadriceps muscle thickness will be measured using ultrasonography, and their relationship with functional capacity, balance, and pain levels will be evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound measurement of popliteus and quadriceps muscle thickness
Popliteus and quadriceps (rectus femoris + vastus intermedius) muscle thickness will be measured via B-mode ultrasonography using a high-frequency linear probe (10-15 MHz), with three measurements averaged per muscle. The correlation between mean popliteus and mean quadriceps thickness (mm) will be assessed using Pearson or Spearman correlation coefficients, depending on data distribution.
Measured: Baseline (single assessment visit)
Timed Up and Go Test (TUG):
The participant sits on a standard armless chair (43-46 cm height); upon the "start" command, they stand up, walk a marked 3-meter distance, turn, walk back to the chair, and sit down. The time elapsed from the start command until the participant sits down is recorded in seconds. The individual wears comfortable footwear, walks at a normal walking speed, and any standard assistive devices (e.g., cane) used are noted
Measured: baseline
5-Times Sit-to-Stand Test (5STS)
It is a reliable test used to assess sitting and standing ability. In older adults, it evaluates functional mobility, lower extremity muscle strength, and balance (19). The participant crosses their arms over their chest, and the time required to complete 5 consecutive sit-to-stand repetitions is measured.
Measured: Baseline
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS is a comprehensive and reliable instrument for knee injuries and knee osteoarthritis. The scale consists of 5 subscales: Pain (9 items), Other Symptoms (7 items), Function in Daily Living (ADL) (17 items), Sport/Recreation Function (5 items), and Knee-Related Quality of Life (4 items). Each subscale is normalized to a score of 0-100, where 100 indicates no problems and 0 indicates extreme problems
Measured: Baseline
Romberg Test
The patient is asked to stand upright with their feet together and arms hanging freely at their sides.The patient must wear hard, thin-soled shoes during this test. Without receiving any support, the patient is asked to stand first with eyes open and then with eyes closed. Safety precautions must be taken during this test to prevent falls; the examiner must remain close to the patient at all times and be prepared to catch them if they fall. In peripheral vestibular pathologies, the direction of sway/fall is toward the side of the lesion
Measured: Baseline
Visual Analog Scale (VAS)
Participants will be asked to mark their average perceived pain intensity on a 10-centimeter (cm) line (defined as 0 = no pain, 10 = unbearable pain) during rest, activity, and sleep. Baseline pain scores will be obtained by measuring the distance between the marked point and the zero point using a ruler
Measured: Baseline
Standardized Mini-Mental State Examination (SMMSE)
Developed by Folstein et al. in 1975 to assess cognitive status in adults. Its validity and reliability for the Turkish population were conducted by Güngen et al. A modified version is also available for individuals with less than five years of education. SMMSE is categorized under five main headings: orientation (10 points), registration/memory (3 points), attention and calculation (5 points), recall (3 points), and language (9 points). The scale is evaluated out of a total of 30 points. In scoring: results between 24 and 30 points indicate "normal" cognitive status, 18 to 23 points indicate "mild dementia," 12 to 17 points indicate "moderate dementia," and scores below 12 indicate "severe dementia" (Güngen et al., 2002). Individuals scoring 24 and above on the SMMSE were included in our study.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start20 Aug 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthritis 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülşen Taşkın, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834827
- Sponsor's protocol ID
- 2026/505
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 22 Sep 2026
- 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Popliteus and Quadriceps Muscle Thickness and Functional Capacity, Balance, and Pain in Elderly Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07834827
- Acronym / sponsor ID
- 2026/505
- Conditions
- Knee Arthritis Osteoarthritis, Balance Assessment
- Keywords
- knee osteoarthritis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 22 Sep 2026 (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 aims to examine the relationships between the ultrasonographic muscle thicknesses of the popliteus and quadriceps muscles and functional capacity, balance, and pain levels in elderly patients with knee osteoarthritis (KOA). Knee osteoarthritis is a major degenerative joint disorder causing pain, stiffness, and reduced mobility, where surrounding muscle architecture plays a pivotal role in functional performance and joint stability. The study will recruit approximately 150 participants aged 65 years and older with Grade 3-4 KOA (Kellgren-Lawrence) and intact cognitive status (SMMSE score ≥24) presenting to the Physical Medicine and Rehabilitation Outpatient Clinic of Afyonkarahisar Health Sciences University Health Application and Research Center, while excluding individuals with central nervous system, visual pathologies, or prior lower extremity surgeries. Muscle thicknesses of the popliteus and quadriceps (rectus femoris and vastus intermedius) will be measured via high-frequency B-mode ultrasonography by a specialist physician, using standardized anatomical landmarks and patient positioning. Functional capacity and mobility will be evaluated using the Timed Up and Go (TUG) and 5-Times Sit-to-Stand (5STS) tests, balance and proprioception via the Romberg Test, and knee-specific functional status and pain severity using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Visual Analog Scale (VAS).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee OA Patients | – | –Elderly patients diagnosed with knee osteoarthritis who meet the inclusion criteria. Popliteus and quadriceps muscle thickness will be measured using ultrasonography, and their relationship with functional capacity, balance, and pain levels will be evaluated. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Participants for this study will consist of individuals aged 65 years and older diagnosed with Grade 3 and Grade 4 knee osteoarthritis according to the Kellgren-Lawrence classification by a specialist physician, presenting to the Physical Medicine and Rehabilitation Outpatient Clinic of Afyonkarahisar Health Sciences University Health Application and Research Center. All evaluations within the scope of the study will be performed at the Physical Medicine and Rehabilitation Outpatient Clinic of Afyonkarahisar Health Sciences University Health Application and Research Center. Ultrasound (US) evaluations of the participants classified under Kellgren-Lawrence Grade 3 and Grade 4 will be performed.
Key inclusion criteria (3 listed)
- Individuals aged 65 years and older
- Individuals with a Standardized Mini-Mental State Examination (SMMSE) score of 24 and above
- Individuals classified as Grade 3-4 according to the Kellgren-Lawrence grading scale
Key exclusion criteria (4 listed)
- Individuals under the age of 65
- Individuals with an SMMSE score below 24
- Individuals with central nervous system and visual pathologies that may affect balance
- Individuals with a history of lower extremity surgery
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
Ultrasound measurement of popliteus and quadriceps muscle thickness
Time frame: Baseline (single assessment visit)
Popliteus and quadriceps (rectus femoris + vastus intermedius) muscle thickness will be measured via B-mode ultrasonography using a high-frequency linear probe (10-15 MHz), with three measurements averaged per muscle. The correlation between mean popliteus and mean quadriceps thickness (mm) will be assessed using Pearson or Spearman correlation coefficients, depending on data distribution.
Timed Up and Go Test (TUG):
Time frame: baseline
The participant sits on a standard armless chair (43-46 cm height); upon the "start" command, they stand up, walk a marked 3-meter distance, turn, walk back to the chair, and sit down. The time elapsed from the start command until the participant sits down is recorded in seconds. The individual wears comfortable footwear, walks at a normal walking speed, and any standard assistive devices (e.g., cane) used are noted
5-Times Sit-to-Stand Test (5STS)
Time frame: Baseline
It is a reliable test used to assess sitting and standing ability. In older adults, it evaluates functional mobility, lower extremity muscle strength, and balance (19). The participant crosses their arms over their chest, and the time required to complete 5 consecutive sit-to-stand repetitions is measured.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline
KOOS is a comprehensive and reliable instrument for knee injuries and knee osteoarthritis. The scale consists of 5 subscales: Pain (9 items), Other Symptoms (7 items), Function in Daily Living (ADL) (17 items), Sport/Recreation Function (5 items), and Knee-Related Quality of Life (4 items). Each subscale is normalized to a score of 0-100, where 100 indicates no problems and 0 indicates extreme problems
Romberg Test
Time frame: Baseline
The patient is asked to stand upright with their feet together and arms hanging freely at their sides.The patient must wear hard, thin-soled shoes during this test. Without receiving any support, the patient is asked to stand first with eyes open and then with eyes closed. Safety precautions must be taken during this test to prevent falls; the examiner must remain close to the patient at all times and be prepared to catch them if they fall. In peripheral vestibular pathologies, the direction of sway/fall is toward the side of the lesion
Visual Analog Scale (VAS)
Time frame: Baseline
Participants will be asked to mark their average perceived pain intensity on a 10-centimeter (cm) line (defined as 0 = no pain, 10 = unbearable pain) during rest, activity, and sleep. Baseline pain scores will be obtained by measuring the distance between the marked point and the zero point using a ruler
Standardized Mini-Mental State Examination (SMMSE)
Time frame: Baseline
Developed by Folstein et al. in 1975 to assess cognitive status in adults. Its validity and reliability for the Turkish population were conducted by Güngen et al. A modified version is also available for individuals with less than five years of education. SMMSE is categorized under five main headings: orientation (10 points), registration/memory (3 points), attention and calculation (5 points), recall (3 points), and language (9 points). The scale is evaluated out of a total of 30 points. In scoring: results between 24 and 30 points indicate "normal" cognitive status, 18 to 23 points indicate "mild dementia," 12 to 17 points indicate "moderate dementia," and scores below 12 indicate "severe dementia" (Güngen et al., 2002). Individuals scoring 24 and above on the SMMSE were included in our study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
Related trials for Knee Arthritis Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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 Arthritis Osteoarthritis and Balance Assessment, run by Afyonkarahisar Health Sciences 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Ultrasound measurement of popliteus and quadriceps muscle thickness (time frame: Baseline (single assessment visit)). The study lists 7 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 22 Sep 2026.