Parkinson DiseaseNCT05424848
Femoral Cartilage Thickness in Parkinson's Disease
An observational study of Parkinson Disease and Articular Cartilage Disorder, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Parkinson's Disease (PD) is a chronic, progressive, degenerative movement disorder characterized by motor and non-motor findings, and the incidence increases with age.There are different methods for the evaluation of articular cartilage in PD. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Articular Cartilage Disorder, Ultrasonography
- What is being tested?
- Ultasonographic measurement
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2022to 11 Dec 2022
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study sample will be included with Parkinson's Disease Patient and healthy control group.
Who may be able to join
- Having Parkinson's
- 50-75 years old
Who cannot join
- Limited cooperation
- The patient has moderate to severe dementia or mental retardation, which may cause limitations in examination, testing and treatment
- The patient's refusal to participate in the study
- Application of total joint prosthesis for the knee area
- Secondary osteoarthritis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Kucukcekmece, 34303
About this study
Official title: Evaluation of Femoral Cartilage Thickness Ultrasonographic Measurement in Parkinson's Disease
Parkinson's Disease (PD) is a chronic, progressive, degenerative movement disorder characterized by motor and non-motor findings, and the incidence increases with age.There are different methods for the evaluation of articular cartilage in PD. The aim of this study is to examine the effect of cartilage thickness evaluated by US on disease stage, motor functions, balance and fall risks in individuals with Parkinson's Disease.
Read the detailed description
Parkinson's Disease (PD) is a chronic, progressive, degenerative movement disorder characterized by motor and non-motor findings, and the incidence increases with age. It is the second most common neurodegenerative disease after Alzheimer's. Although the incidence of PD increases with age, early onset can also be seen in genetic variants. The prevalence of PD is 1% at the age of 65 and reaches 5% at the age of 85 years. Although the onset of the disease is usually between the ages of 65-70, the diagnosis is made under the age of 40 in 5% of patients. Although the progression process of PH varies between individuals, it has physical, psychological and socioeconomic effects on patients and families in the later stages of the disease. In the advanced stages of the disease, serious complications can be seen, including pneumonia, which can cause mortality.During the course of the disease, rigidity, resting tremor, postural instability, gait disturbance and bradykinesia characterized by progressive decrease in speed and amplitude of repetitive movements are the main cardinal motor findings. In addition to these findings, secondary motor symptoms such as bradymymia, dysarthria, and associated movements in the arm accompany the disease during its course.There are different methods for the evaluation of articular cartilage. Although arthroscopy is the most reliable of these methods, the fact that it is an invasive method limits its applicability. Magnetic Resonance imaging, on the other hand, is a reliable and non-invasive method, but it is expensive and some patients do not prefer this method due to claustrophobia, which limits its use. Although the most commonly used method today is conventional radiography, this method is insufficient to evaluate cartilage thickness. In recent years, ultrasonography (US) has found a very wide area of use for physicians dealing with musculoskeletal diseases.US is accepted as a cost-effective method that allows the patient to feel the least discomfort, provides simultaneous imaging, and allows repeated dynamic evaluations.In addition to being used in the diagnosis and follow-up of various diseases, it allows quantitative measurements of various structures. Likewise, in vivo and in vitro studies have reported that sagittal and axial measurements of femoral cartilage thickness using US measurement are reliable. The most important disease associated with cartilage loss in the literature is osteoarthritis.
The aim of this study is to examine the effect of cartilage thickness evaluated by US on disease stage, motor functions, balance and fall risks in individuals with Parkinson's Disease.
- Being tested
- Ultasonographic measurement
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultasonographic measurementOther
Ultrasonographic measurements of the patients will be evaluated by Dr. Merve Damla Korkmaz. Patients will be positioned in a semi-dark room with the knees fully flexed. Ultrasonographic measurements will be made to evaluate the femoral cartilage thickness of both knees, with images taken from the suprapatellar axillary position. Images of the intercondylar area, lateral and medial femoral condyles of the right and left knees will be taken and the measurements will be made from these areas, 3 measurements will be taken from each knee and the average of these measurements will be taken.
| Study group | Role | What they receive |
|---|---|---|
| patient group | Inclusion Criteria
1. Having Parkinson's
2. 50-75 years old
Exclusion criteria
1. Limited cooperation
2. The patient has moderate to severe dementia or mental retardation, which may cause limitations in examination, testing and treatment
3. The patient's refusal to participate in the study
4. Application of total joint prosthesis for the knee area
5. Secondary osteoarthritis Receives: Other: Ultasonographic measurement | |
| Control group | Healthy control group Receives: Other: Ultasonographic measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic measurement
Images of the intercondylar area, lateral and medial femoral condyles of the right and left knees will be taken and the measurements will be made from these areas, 3 measurements will be taken from each knee and the average of these measurements will be taken.
Measured: Baseline
The Hoehn and Yahr Scale
All patients in this study were classified based on the Hoehn and Yahr scale prior to treatment. This scale is widely used for classifying PD into five stages. It permits objective evaluation of the progression of the disease, from Stage 0 (no disease symptoms) to Stage 5 (the patient is confined to a wheelchair or bed)
Measured: Baseline
The Movement Disorder Society Unified Parkinson's Disease rating Scale (MDS-UPDRS)
This is an extensive scale employed for the clinical evaluation of severity of PD. It consists of four sections including non-motor findings, motor problems, motor findings, and treatment complications
Measured: Baseline
Secondary outcomes (2)
Beck Depression Inventory (BDI)
The BDI is used to evaluate physical, emotional, and cognitive symptoms encountered in depression, such as hopelessness, irritability, guilt, fatigue, and weight loss. Scoring is performed from absence of symptoms to severe symptoms. Total scores range between 0 (no depression) and 63 (severe depression).
Measured: Baseline
International Falls Efficacy Scale (FES)
This 10-question scale evaluated the individual's daily living activities. Subjects are asked how safe they feel when performing these activities, each question being scores from 1 (not at all concerned) to 10 (very concerned). Scoring is based out of a total possible score of 100, with scores of 70 or more indicating a fear of falling.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start15 Jun 2022
- Primary completion25 Nov 2022
- Study completion11 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Damla Korkmaz, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- merve damla korkmaz, M.D., Principal investigator, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424848
- Sponsor's protocol ID
- KAEK/2022.01.3
- Status last verified
- Dec 2022
- First submitted
- 13 Jun 2022
- Last updated
- 27 Dec 2022
- 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 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Femoral Cartilage Thickness Ultrasonographic Measurement in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05424848
- Acronym / sponsor ID
- KAEK/2022.01.3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 11 Dec 2022 (actual)
- First posted
- 21 Jun 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.
Parkinson's Disease (PD) is a chronic, progressive, degenerative movement disorder characterized by motor and non-motor findings, and the incidence increases with age.There are different methods for the evaluation of articular cartilage in PD. The aim of this study is to examine the effect of cartilage thickness evaluated by US on disease stage, motor functions, balance and fall risks in individuals with Parkinson's Disease.
Detailed description
Parkinson's Disease (PD) is a chronic, progressive, degenerative movement disorder characterized by motor and non-motor findings, and the incidence increases with age. It is the second most common neurodegenerative disease after Alzheimer's. Although the incidence of PD increases with age, early onset can also be seen in genetic variants. The prevalence of PD is 1% at the age of 65 and reaches 5% at the age of 85 years. Although the onset of the disease is usually between the ages of 65-70, the diagnosis is made under the age of 40 in 5% of patients. Although the progression process of PH varies between individuals, it has physical, psychological and socioeconomic effects on patients and families in the later stages of the disease. In the advanced stages of the disease, serious complications can be seen, including pneumonia, which can cause mortality.During the course of the disease, rigidity, resting tremor, postural instability, gait disturbance and bradykinesia characterized by progressive decrease in speed and amplitude of repetitive movements are the main cardinal motor findings. In addition to these findings, secondary motor symptoms such as bradymymia, dysarthria, and associated movements in the arm accompany the disease during its course.There are different methods for the evaluation of articular cartilage. Although arthroscopy is the most reliable of these methods, the fact that it is an invasive method limits its applicability. Magnetic Resonance imaging, on the other hand, is a reliable and non-invasive method, but it is expensive and some patients do not prefer this method due to claustrophobia, which limits its use. Although the most commonly used method today is conventional radiography, this method is insufficient to evaluate cartilage thickness. In recent years, ultrasonography (US) has found a very wide area of use for physicians dealing with musculoskeletal diseases.US is accepted as a cost-effective method that allows the patient to feel the least discomfort, provides simultaneous imaging, and allows repeated dynamic evaluations.In addition to being used in the diagnosis and follow-up of various diseases, it allows quantitative measurements of various structures. Likewise, in vivo and in vitro studies have reported that sagittal and axial measurements of femoral cartilage thickness using US measurement are reliable. The most important disease associated with cartilage loss in the literature is osteoarthritis.
The aim of this study is to examine the effect of cartilage thickness evaluated by US on disease stage, motor functions, balance and fall risks in individuals with Parkinson's Disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient group | – | Other: Ultasonographic measurementInclusion Criteria 1. Having Parkinson's 2. 50-75 years old Exclusion criteria 1. Limited cooperation 2. The patient has moderate to severe dementia or mental retardation, which may cause limitations in examination, testing and treatment 3. The patient's refusal to participate in the study 4. Application of total joint prosthesis for the knee area 5. Secondary osteoarthritis |
| Control group | – | Other: Ultasonographic measurementHealthy control group |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study sample will be included with Parkinson's Disease Patient and healthy control group.
Key inclusion criteria (2 listed)
- Having Parkinson's
- 50-75 years old
Key exclusion criteria (5 listed)
- Limited cooperation
- The patient has moderate to severe dementia or mental retardation, which may cause limitations in examination, testing and treatment
- The patient's refusal to participate in the study
- Application of total joint prosthesis for the knee area
- Secondary osteoarthritis
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 |
|---|---|---|
| Ultasonographic measurementUltrasonographic measurements of the patients will be evaluated by Dr. Merve Damla Korkmaz. Patients will be positioned in a semi-dark room with the knees fully flexed. Ultrasonographic measurements will be made to evaluate the femoral cartilage thickness of both knees, with images taken from the suprapatellar axillary position. Images of the intercondylar area, lateral and medial femoral condyles of the right and left knees will be taken and the measurements will be made from these areas, 3 measurements will be taken from each knee and the average of these measurements will be taken. | Other | Control group, patient group |
Primary outcome
Ultrasonographic measurement
Time frame: Baseline
Images of the intercondylar area, lateral and medial femoral condyles of the right and left knees will be taken and the measurements will be made from these areas, 3 measurements will be taken from each knee and the average of these measurements will be taken.
The Hoehn and Yahr Scale
Time frame: Baseline
All patients in this study were classified based on the Hoehn and Yahr scale prior to treatment. This scale is widely used for classifying PD into five stages. It permits objective evaluation of the progression of the disease, from Stage 0 (no disease symptoms) to Stage 5 (the patient is confined to a wheelchair or bed)
The Movement Disorder Society Unified Parkinson's Disease rating Scale (MDS-UPDRS)
Time frame: Baseline
This is an extensive scale employed for the clinical evaluation of severity of PD. It consists of four sections including non-motor findings, motor problems, motor findings, and treatment complications
2 secondary outcomes
Beck Depression Inventory (BDI)
Time frame: Baseline
International Falls Efficacy Scale (FES)
Time frame: Baseline
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 27 Dec 2022.
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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.
merve damla korkmaz, M.D. principal investigator
Kanuni Sultan Suleyman Training and Research Hospital
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 Parkinson Disease and Articular Cartilage Disorder, run by Kanuni Sultan Suleyman Training and Research Hospital 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 5 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 27 Dec 2022. 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?
Ultrasonographic measurement (time frame: Baseline). 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 27 Dec 2022.