Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062540) titled 'Longitudinal Evaluation of Activities of Daily Living in Patients with Parkinsons Disease Using Markerless Motion Analysis' on Aug. 10.

Study Type: Observational

Primary Sponsor: Institute - Hokkaido University

Condition: Condition - Parkinsons Disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to longitudinally assess activities of daily living (ADL) in patients with Parkinson's disease using an AI-based markerless motion analysis system and to characterize changes in kinematic parameters, including joint range of motion, movement time, velocity, and acceleration, according to disease severity and progression. In addition, this study will examine the associations between these kinematic parameters and conventional clinical measures, including the Hoehn and Yahr stage, the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), and the Schwab and England Activities of Daily Living Scale (S&E ADLs), and determine whether markerless motion analysis can detect longitudinal changes in ADL performance more sensitively than conventional clinical assessments. Basic objectives2 - Bio-equivalence

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Patients diagnosed with Parkinson's disease (PD) by a physician

2. Patients aged 18 years or older at the time of informed consent

3. Patients classified as Hoehn and Yahr stage I to III

4. Patients who can safely perform the study-related activities, including grooming, eating, dressing, standing up from a chair, and walking, with supervision or their usual assistive devices as needed

5. Patients who can understand the study procedures and provide written informed consent voluntarily

6. Patients considered eligible for participation by the principal investigator, study investigators, or attending physician Key exclusion criteria - 1. Patients with neurological diseases other than Parkinsons disease that are considered to have a substantial effect on the movements assessed in this study

2. Patients for whom safe motion assessment is considered difficult because of severe musculoskeletal disorders, cardiac disease, respiratory disease, dizziness, acute illness, or other systemic conditions

3. Patients who have difficulty understanding the study, providing written informed consent, or performing the assessment tasks because of impaired cognitive function or communication ability

4. Patients for whom assessment is considered inappropriate because of pain, marked fatigue, fever, or other poor physical conditions

5. Patients considered unsuitable for participation by the principal investigator, study investigators, or attending physician Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 10 Day Anticipated trial start date - 2026 Year 09 Month 10 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071591

Disclaimer: Curated by HT Syndication.