NCT05424848

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2022

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

June 13, 2022

Last Update Submit

December 22, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Beck Depression Inventory (BDI)

    Baseline

  • International Falls Efficacy Scale (FES)

    Baseline

Study Arms (2)

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

Other: Ultasonographic measurement

Control group

Healthy control group

Other: Ultasonographic measurement

Interventions

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 grouppatient group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Having Parkinson's
  • years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Kucukcekmece, 34303, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • merve damla korkmaz, M.D.

    Kanuni Sultan Suleyman Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 13, 2022

First Posted

June 21, 2022

Study Start

June 15, 2022

Primary Completion

November 25, 2022

Study Completion

December 11, 2022

Last Updated

December 27, 2022

Record last verified: 2022-12

Locations