Femoral Cartilage Thickness in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Evaluation of Femoral Cartilage Thickness Ultrasonographic Measurement in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05424848
• Other study ID #: KAEK/2022.01.3
• Status: Completed
• Start date: June 15, 2022
• Est. completion date: December 11, 2022

Study information

• Verified date: December 2022
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 11, 2022
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Having Parkinson's
• 50-75 years old

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Articular Cartilage Disorder
• Cartilage Diseases
• Parkinson Disease
• Ultrasonography

Intervention

Other:
• Ultasonographic measurement
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.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul	Kucukcekmece

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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)	Baseline
Primary	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	Baseline
Secondary	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).	Baseline
Secondary	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.	Baseline