Knee OsteoarthritisNCT06319937
Muscle Architecture in Knee Osteoarthritis
A study testing Ultrasound in people with Knee Osteoarthritis and Foot Deformities, run by Hacettepe University.
Trial summary
Background: The aim of this study was to compare the knee and ankle muscle architecture and plantar pressure distribution differences in knee osteoarthritis (OA) women with healthy women. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Knee Osteoarthritis, Foot Deformities, Muscle Weakness
- What is being tested?
- Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Sep 2025
- Phase
- Interventional
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 45-65 years
- Activity-related knee pain
- Morning knee stiffness for 30 min
- Knee pain on most days for 3 months or more
Who cannot join
- Having lower extremity surgery
- Conditions that cause congenital or developmental diseases
- The presence of systemic inflammatory arthritis
- Polyneuropathy/lower extremity neuropathy, severe radiculopathy
- Having undergone physical therapy, exercises or knee injections for the knee in the previous 6 months
- Congenital foot deformity
- BMI higher than 35 kg/m2
About this study
Official title: The Role of Muscle Architecture as a Determinant of Functional Performance in Women With Knee Osteoarthritis
Background: The aim of this study was to compare the knee and ankle muscle architecture and plantar pressure distribution differences in knee osteoarthritis (OA) women with healthy women.
Methods: Fifty women with knee OA (Mean age=52.11±4.96 years, mean BMI=30.94±4.23 kg/m2) and fifty healthy women (Mean age= 50.93±3.78 years, mean BMI=29.06±4.82 kg/m2) were included in the study. Ultrasonography was used to evaluate Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Peroneus Longus (PL), Tibialis Anterior (TA), and Medial Gastrocnemius (MG) muscle thickness, pennation angle, fascicle length, and fat thickness. The plantar pressure distribution was evaluated using the Digital Biometry Scanning System and software (DIASU, Italy).
Read the detailed description
The following measurements were performed in subjects with knee osteoarthritis and healthy subjects with similar age-BMI and then a comparison was made between the 2 groups.
Measurements Pain severity: The Visual Analogue Scale (VAS) was used to assess the severity of knee and foot pain during activity. The 10-cm horizontal line was defined as 0 "no pain" and 10 "very severe pain", and the patients were asked to indicate their knee and foot pain level by drawing a line. This line was then measured in centimeters on both the dominant and non-dominant side.
Static foot posture: The Foot Posture Index (FPI) was used to evaluate foot posture in a relaxed position while standing. The FPI is showed to be a valid and reliable tool in individuals with knee OA. The FPI consisted of six items: 1) palpation of the talar head, 2) assessment of the curvature of the supra and infra lateral malleolus, 3) evaluation of the frontal plane position of the calcaneus, 4) identification of any prominence in the region of the talonavicular joint, 5) examination of the congruence of the medial longitudinal arch, and 6) measurement of abduction/adduction of the forefoot on the rear foot. Each item was scored from -2 to +2, and the total score ranged from -12 to +12. A higher positive score indicated a more pronated foot. A score of ≥6 indicated a pronated foot type, while scores of 0-5 indicated a neutral foot type, and scores of ≤-1 indicated a supinated foot type. OA side and dominant side assessed. All data on static foot posture were collected by the physiotherapist who has 5 years of experience in foot assessment (X). To avoid bias, the physiotherapist performing the assessment did not know which group the individuals were in.
Muscle architecture: Ultrasound, which is a measurement method with validity and reliability in individuals with knee OA, was used to evaluate the knee and ankle muscles. A total of six muscles were evaluated, including three knee muscles and three ankle muscles: Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Tibialis Anterior (TA), Peroneus Longus (PL) and Medial Gastrocnemius (MG). The muscle thickness, pennation angle, fascicle length and fat thickness of each muscle were evaluated using B-Mode ultrasonography (E-Saote MyLab X8 eXP Ultrasound System, Florence, Italy) and a linear array transducer (4-11.4 MHz). It has been mentioned that there is muscle weakness in the muscles around the knee in knee OA, and in line with the investigators' hypothesis, the investigators thought that there may be differences in the muscles around the foot in these patients, so the investigators preferred to evaluate these muscles. All data on muscle architecture were collected by the same rheumatologist who has 5 years of experience in ultrasound assessment.
The images of the RF, VM, VL, and TA muscles were obtained with participants in a supine position. For the MG and PL muscle images, participants were instructed to lie prone. To enhance reproducibility and minimize the risk of sampling a muscle obliquely, the transducer was oriented parallel to the muscle fascicles and perpendicular to the skin.
The image was regarded as optimized when a thin layer of gel was visible between the skin and the transducer, signifying that no manual compressive forces were distorting the muscle after it had been identified. The same researcher then slightly retracted the transducer to avoid compressing the muscle. Ultrasound images were analyzed using Image J program (Version 1.53p, 2022, National Institutes of Health, Bethesda, MD, USA) by the same researcher. The same procedure was employed for each muscle group, with measurements taken of both muscle architecture and fat thickness. Following completion of all images from the first extremity, the identical technique was utilized to image the opposite lower extremity. Muscle thickness was measured as the distance between the internal borders of the superficial and deep aponeuroses. Fat thickness of all muscles was measured as the distance between the skin of the superficial aponeuroses. Pennation angle was defined as the angle between the muscle fascicle line and the deep aponeuroses. Fascicle length was defined as the distance between the origin of the fascicle at the superficial aponeuroses and insertion of the same fascicle in the deep aponeuroses.
Femoral cartilage thickness: In order to determine femoral cartilage thickness, individuals assumed a supine position with their knees comfortably flexed to the maximum extent. The probe was positioned axially on the suprapatellar region. Femoral cartilage thickness was assessed at three discrete points on both knees, specifically at the levels of the lateral condyle, intercondylar area, and medial condyle. Water-soluble gel was applied between the transducer and the skin to support acoustic coupling, without applying pressure to the muscle. The transducer was oriented axially above the patellar outer edge. In addition, femoral cartilage thickness measurement is a valid and reliable measurement.
Plantar pressure distribution: Plantar pressure distribution was performed by the Digital Biometric Images Scanning System and relevant Milletrix software (Diagnostic Support; Diasu Health Technologies, Rome, Italy). The platform employed in this study comprised a 5-meter long and 40-centimeter wide walkway equipped with 4024 sensors that could sample data at a frequency of 300 MHz. The force platform assessed plantar pressure on both feet while standing, and it calculated the average percentage of pressure distribution for each foot. Participants were instructed to stand barefoot on the platform for 10 seconds, facing a reference point, with their arms hanging comfortably by their sides. During these measurements, the patients were instructed not to consciously adjust their posture.
The static evaluation provided information on numerical surface and loading values, both globally (for each foot) and partially (relative to the rearfoot, forefoot, medial and lateral load). The maximum foot pressure (FPmax), average foot pressure (Pavg.), total surface area, forefoot load (FFL), rearfoot load (RFL), total load on the foot, medial load, lateral load, foot angle (FA) and foot progression angle (FPA) of the women were recorded. Foot angle is the angle between the direction of progression of the individual and a reference line on the sole of each foot. Foot progression angle is the angle between the longitudinal foot axis and the vertical axis of the foot. The plantar pressure distribution outcomes of the related knee in patients with unilateral involvement and the most symptomatic knee in patients with bilateral knee involvement were compared with matched knees of the healthy controls . To ensure blinding in the study, plantar pressure distribution was performed by a physiotherapist with 7 years of experience in this field. To avoid bias, the physiotherapist performing the assessment did not know which group the individuals were in.
Kinesiophobia: The Tampa Kinesiophobia Scale (TKS) was used to assess fear of movement-related pain. This scale, consisting of twenty-three items, assesses the inhibition or fear of movement due to feelings of vulnerability caused by painful conditions. The total score ranges from 17 to 68 points. A high score on the scale indicates a high level of kinesiophobia.
Functional Performance : Functional performance was assessed using the stair-climbing test (SCT) and the 10-time sit-stand test (SST), which were approved for use in individuals with KOA and recommended by the International Osteoarthritis Research Association. For the SCT, individuals were asked to ascend, turn around, and descend a flight of 10 steps as quickly as possible, using one handrail if necessary. The time to ascend and descend was measured. For the SST, individuals were asked to stand up completely straight from a chair with armrests, and sit down again without support from their arms, and repeat this 10 times at the fastest pace they could. The time during this procedure was recorded.
- Conditions
- Knee Osteoarthritis, Foot Deformities, Muscle Weakness, Kinesiophobia
- Being tested
- Ultrasound
- Keywords
- knee osteoarthritis, ultrasonography, kinesiophobia, functional performance, muscles, foot
- Medical subject headings
- Osteoarthritis, Knee, Foot Deformities, Muscle Weakness, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| OA Group | Experimental | Knee OA were included in the study. All patients exhibited evident radiographic changes in either unilateral or bilateral knees, consistent with a diagnosis of osteoarthritis, and were classified as Kellgren Lawrence (K-L) grade 2. Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle thickness
Muscle thickness of Rectus Femoris, Vastus Medialis, Vastus Lateralis, Medial Gastrocnemius, Peronalis Longus.
Muscle thickness of Rectus Femoris, Vastus Medialis, Vastus Lateralis, Medial Gastrocnemius, Peronalis Longus.
Ultrasound, which is a measurement method with validity and reliability in individuals with knee OA, was used to evaluate the knee and ankle muscles. A total of six muscles were evaluated, including three knee muscles and three ankle muscles: Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Tibialis Anterior (TA), Peroneus Longus (PL) and Medial Gastrocnemius (MG). The muscle thickness of each muscle were evaluated using B-Mode ultrasonography (Esaote MyLab X8 eXP Ultrasound System, Florence, Italy) and a linear array transducer (4-11.4 MHz)
Measured: 15 days
Pennation angle
Pennation angle of Rectus Femoris, Vastus Medialis, Vastus Lateralis, Medial Gastrocnemius, Peronalis Longus.
Ultrasound, which is a measurement method with validity and reliability in individuals with knee OA, was used to evaluate the knee and ankle muscles. A total of six muscles were evaluated, including three knee muscles and three ankle muscles: Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Tibialis Anterior (TA), Peroneus Longus (PL) and Medial Gastrocnemius (MG). The pennation angle of each muscle were evaluated using B-Mode ultrasonography (Esaote MyLab X8 eXP Ultrasound System, Florence, Italy) and a linear array transducer (4-11.4 MHz)
Measured: 15 days
Fat thickness
Fat thickness of Rectus Femoris, Vastus Medialis, Vastus Lateralis, Medial Gastrocnemius, Peronalis Longus.
Ultrasound, which is a measurement method with validity and reliability in individuals with knee OA, was used to evaluate the knee and ankle muscles. A total of six muscles were evaluated, including three knee muscles and three ankle muscles: Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Tibialis Anterior (TA), Peroneus Longus (PL) and Medial Gastrocnemius (MG). The fat thickness of each muscle were evaluated using B-Mode ultrasonography (Esaote MyLab X8 eXP Ultrasound System, Florence, Italy) and a linear array transducer (4-11.4 MHz)
Measured: 15 days
Secondary outcomes (2)
Stair climbing test
Functional performance was assessed using the stair-climbing test (SCT) time which were approved for use in individuals with KOA and recommended by the International Osteoarthritis Research Association. For the SCT, individuals were asked to ascend, turn around, and descend a flight of 10 steps as quickly as possible, using one handrail if necessary. The time to ascend and descend was measured.
Measured: 15 days
Sit-stand test
Functional performance was assessed using the 10-time sit-stand test (SST), which were approved for use in individuals with KOA and recommended by the International Osteoarthritis Research Association. For the SST, individuals were asked to stand up completely straight from a chair with armrests, and sit down again without support from their arms, and repeat this 10 times at the fastest pace they could. The time during this procedure was recorded.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HANDE GUNEY, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319937
- Sponsor's protocol ID
- OA2023
- Status last verified
- Mar 2024
- First submitted
- 26 Jan 2024
- Last updated
- 20 Mar 2024
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Muscle Architecture as a Determinant of Functional Performance in Women With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06319937
- Acronym / sponsor ID
- OA2023
- Conditions
- Knee Osteoarthritis, Foot Deformities, Muscle Weakness, Kinesiophobia
- Keywords
- knee osteoarthritis, ultrasonography, kinesiophobia, functional performance, muscles, foot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 20 Mar 2024 (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.
Background: The aim of this study was to compare the knee and ankle muscle architecture and plantar pressure distribution differences in knee osteoarthritis (OA) women with healthy women.
Methods: Fifty women with knee OA (Mean age=52.11±4.96 years, mean BMI=30.94±4.23 kg/m2) and fifty healthy women (Mean age= 50.93±3.78 years, mean BMI=29.06±4.82 kg/m2) were included in the study. Ultrasonography was used to evaluate Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Peroneus Longus (PL), Tibialis Anterior (TA), and Medial Gastrocnemius (MG) muscle thickness, pennation angle, fascicle length, and fat thickness. The plantar pressure distribution was evaluated using the Digital Biometry Scanning System and software (DIASU, Italy).
Detailed description
The following measurements were performed in subjects with knee osteoarthritis and healthy subjects with similar age-BMI and then a comparison was made between the 2 groups.
Measurements Pain severity: The Visual Analogue Scale (VAS) was used to assess the severity of knee and foot pain during activity. The 10-cm horizontal line was defined as 0 "no pain" and 10 "very severe pain", and the patients were asked to indicate their knee and foot pain level by drawing a line. This line was then measured in centimeters on both the dominant and non-dominant side.
Static foot posture: The Foot Posture Index (FPI) was used to evaluate foot posture in a relaxed position while standing. The FPI is showed to be a valid and reliable tool in individuals with knee OA. The FPI consisted of six items: 1) palpation of the talar head, 2) assessment of the curvature of the supra and infra lateral malleolus, 3) evaluation of the frontal plane position of the calcaneus, 4) identification of any prominence in the region of the talonavicular joint, 5) examination of the congruence of the medial longitudinal arch, and 6) measurement of abduction/adduction of the forefoot on the rear foot. Each item was scored from -2 to +2, and the total score ranged from -12 to +12. A higher positive score indicated a more pronated foot. A score of ≥6 indicated a pronated foot type, while scores of 0-5 indicated a neutral foot type, and scores of ≤-1 indicated a supinated foot type. OA side and dominant side assessed. All data on static foot posture were collected by the physiotherapist who has 5 years of experience in foot assessment (X). To avoid bias, the physiotherapist performing the assessment did not know which group the individuals were in.
Muscle architecture: Ultrasound, which is a measurement method with validity and reliability in individuals with knee OA, was used to evaluate the knee and ankle muscles. A total of six muscles were evaluated, including three knee muscles and three ankle muscles: Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Tibialis Anterior (TA), Peroneus Longus (PL) and Medial Gastrocnemius (MG). The muscle thickness, pennation angle, fascicle length and fat thickness of each muscle were evaluated using B-Mode ultrasonography (E-Saote MyLab X8 eXP Ultrasound System, Florence, Italy) and a linear array transducer (4-11.4 MHz). It has been mentioned that there is muscle weakness in the muscles around the knee in knee OA, and in line with the investigators' hypothesis, the investigators thought that there may be differences in the muscles around the foot in these patients, so the investigators preferred to evaluate these muscles. All data on muscle architecture were collected by the same rheumatologist who has 5 years of experience in ultrasound assessment.
The images of the RF, VM, VL, and TA muscles were obtained with participants in a supine position. For the MG and PL muscle images, participants were instructed to lie prone. To enhance reproducibility and minimize the risk of sampling a muscle obliquely, the transducer was oriented parallel to the muscle fascicles and perpendicular to the skin.
The image was regarded as optimized when a thin layer of gel was visible between the skin and the transducer, signifying that no manual compressive forces were distorting the muscle after it had been identified. The same researcher then slightly retracted the transducer to avoid compressing the muscle. Ultrasound images were analyzed using Image J program (Version 1.53p, 2022, National Institutes of Health, Bethesda, MD, USA) by the same researcher. The same procedure was employed for each muscle group, with measurements taken of both muscle architecture and fat thickness. Following completion of all images from the first extremity, the identical technique was utilized to image the opposite lower extremity. Muscle thickness was measured as the distance between the internal borders of the superficial and deep aponeuroses. Fat thickness of all muscles was measured as the distance between the skin of the superficial aponeuroses. Pennation angle was defined as the angle between the muscle fascicle line and the deep aponeuroses. Fascicle length was defined as the distance between the origin of the fascicle at the superficial aponeuroses and insertion of the same fascicle in the deep aponeuroses.
Femoral cartilage thickness: In order to determine femoral cartilage thickness, individuals assumed a supine position with their knees comfortably flexed to the maximum extent. The probe was positioned axially on the suprapatellar region. Femoral cartilage thickness was assessed at three discrete points on both knees, specifically at the levels of the lateral condyle, intercondylar area, and medial condyle. Water-soluble gel was applied between the transducer and the skin to support acoustic coupling, without applying pressure to the muscle. The transducer was oriented axially above the patellar outer edge. In addition, femoral cartilage thickness measurement is a valid and reliable measurement.
Plantar pressure distribution: Plantar pressure distribution was performed by the Digital Biometric Images Scanning System and relevant Milletrix software (Diagnostic Support; Diasu Health Technologies, Rome, Italy). The platform employed in this study comprised a 5-meter long and 40-centimeter wide walkway equipped with 4024 sensors that could sample data at a frequency of 300 MHz. The force platform assessed plantar pressure on both feet while standing, and it calculated the average percentage of pressure distribution for each foot. Participants were instructed to stand barefoot on the platform for 10 seconds, facing a reference point, with their arms hanging comfortably by their sides. During these measurements, the patients were instructed not to consciously adjust their posture.
The static evaluation provided information on numerical surface and loading values, both globally (for each foot) and partially (relative to the rearfoot, forefoot, medial and lateral load). The maximum foot pressure (FPmax), average foot pressure (Pavg.), total surface area, forefoot load (FFL), rearfoot load (RFL), total load on the foot, medial load, lateral load, foot angle (FA) and foot progression angle (FPA) of the women were recorded. Foot angle is the angle between the direction of progression of the individual and a reference line on the sole of each foot. Foot progression angle is the angle between the longitudinal foot axis and the vertical axis of the foot. The plantar pressure distribution outcomes of the related knee in patients with unilateral involvement and the most symptomatic knee in patients with bilateral knee involvement were compared with matched knees of the healthy controls . To ensure blinding in the study, plantar pressure distribution was performed by a physiotherapist with 7 years of experience in this field. To avoid bias, the physiotherapist performing the assessment did not know which group the individuals were in.
Kinesiophobia: The Tampa Kinesiophobia Scale (TKS) was used to assess fear of movement-related pain. This scale, consisting of twenty-three items, assesses the inhibition or fear of movement due to feelings of vulnerability caused by painful conditions. The total score ranges from 17 to 68 points. A high score on the scale indicates a high level of kinesiophobia.
Functional Performance : Functional performance was assessed using the stair-climbing test (SCT) and the 10-time sit-stand test (SST), which were approved for use in individuals with KOA and recommended by the International Osteoarthritis Research Association. For the SCT, individuals were asked to ascend, turn around, and descend a flight of 10 steps as quickly as possible, using one handrail if necessary. The time to ascend and descend was measured. For the SST, individuals were asked to stand up completely straight from a chair with armrests, and sit down again without support from their arms, and repeat this 10 times at the fastest pace they could. The time during this procedure was recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OA Group | Experimental | Diagnostic Test: UltrasoundKnee OA were included in the study. All patients exhibited evident radiographic changes in either unilateral or bilateral knees, consistent with a diagnosis of osteoarthritis, and were classified as Kellgren Lawrence (K-L) grade 2. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 45-65 years
- Activity-related knee pain
- Morning knee stiffness for 30 min
- Knee pain on most days for 3 months or more
Key exclusion criteria (7 listed)
- Having lower extremity surgery
- Conditions that cause congenital or developmental diseases
- The presence of systemic inflammatory arthritis
- Polyneuropathy/lower extremity neuropathy, severe radiculopathy
- Having undergone physical therapy, exercises or knee injections for the knee in the previous 6 months
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 |
|---|---|---|
| UltrasoundUltrasound | Diagnostic test | OA Group |
Primary outcome
Muscle thickness
Time frame: 15 days
Muscle thickness of Rectus Femoris, Vastus Medialis, Vastus Lateralis, Medial Gastrocnemius, Peronalis Longus. Muscle thickness of Rectus Femoris, Vastus Medialis, Vastus Lateralis, Medial Gastrocnemius, Peronalis Longus. Ultrasound, which is a measurement method with validity and reliability in individuals with knee OA, was used to evaluate the knee and ankle muscles. A total of six muscles were evaluated, including three knee muscles and three ankle muscles: Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Tibialis Anterior (TA), Peroneus Longus (PL) and Medial Gastrocnemius (MG). The muscle thickness of each muscle were evaluated using B-Mode ultrasonography (Esaote MyLab X8 eXP Ultrasound System, Florence, Italy) and a linear array transducer (4-11.4 MHz)
Pennation angle
Time frame: 15 days
Pennation angle of Rectus Femoris, Vastus Medialis, Vastus Lateralis, Medial Gastrocnemius, Peronalis Longus. Ultrasound, which is a measurement method with validity and reliability in individuals with knee OA, was used to evaluate the knee and ankle muscles. A total of six muscles were evaluated, including three knee muscles and three ankle muscles: Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Tibialis Anterior (TA), Peroneus Longus (PL) and Medial Gastrocnemius (MG). The pennation angle of each muscle were evaluated using B-Mode ultrasonography (Esaote MyLab X8 eXP Ultrasound System, Florence, Italy) and a linear array transducer (4-11.4 MHz)
Fat thickness
Time frame: 15 days
Fat thickness of Rectus Femoris, Vastus Medialis, Vastus Lateralis, Medial Gastrocnemius, Peronalis Longus. Ultrasound, which is a measurement method with validity and reliability in individuals with knee OA, was used to evaluate the knee and ankle muscles. A total of six muscles were evaluated, including three knee muscles and three ankle muscles: Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Tibialis Anterior (TA), Peroneus Longus (PL) and Medial Gastrocnemius (MG). The fat thickness of each muscle were evaluated using B-Mode ultrasonography (Esaote MyLab X8 eXP Ultrasound System, Florence, Italy) and a linear array transducer (4-11.4 MHz)
2 secondary outcomes
Stair climbing test
Time frame: 15 days
Sit-stand test
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Knee Osteoarthritis and Foot Deformities, run by Hacettepe University.
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 4 inclusion and 7 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 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Muscle thickness (time frame: 15 days). The study lists 3 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 20 Mar 2024.