Femoral Cartilage Thickness in Parkinson's Disease

December 22, 2022 updated by: Merve Damla Korkmaz, Kanuni Sultan Suleyman Training and Research Hospital

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kucukcekmece
      • Istanbul, Kucukcekmece, Turkey, 34303
        • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study sample will be included with Parkinson's Disease Patient and healthy control group.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Control group
Healthy control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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)
Baseline
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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory (BDI)
Time Frame: Baseline
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
International Falls Efficacy Scale (FES)
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: merve damla korkmaz, M.D., Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2022

Primary Completion (Actual)

November 25, 2022

Study Completion (Actual)

December 11, 2022

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 15, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

December 27, 2022

Last Update Submitted That Met QC Criteria

December 22, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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