Fall Risk Assessment in Parkinson's Disease Using Kinetikos Health

N/ANot Yet RecruitingNCT07257393

Taipei Medical University Shuang Ho Hospital100 enrolled

Overview

This is a single-center, prospective observational study aiming to validate the Kinetikos Health App for fall risk assessment in PD patients undergoing dopaminergic medication adjustments.

Falls are common and disabling in PD. Dopaminergic medication effects on fall risk remain inconclusive. This study validates the Kinetikos Health App for objective fall risk assessment before and after medication adjustment.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Idiopathic Parkinsonism

Interventions

No Intervention: Observational CohortOTHER

No intervention.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥20; 2. PD diagnosis (MDS criteria); 3. On levodopa monotherapy with motor fluctuations; 4. Planned to start opicapone or safinamide; 5. Consent provided. Exclusion Criteria: 1. Atypical/secondary parkinsonism; 2. Moderate-severe dementia; 3. DBS/MRgFUS/neurosurgery within 6 months; 4. Severe comorbidities limiting test

Locations (1)

Shuang Ho Hospital, Taipei Medical University

New Taipei City, Taiwan

Outcomes

Primary Outcomes

Change in fall-risk index (Kinetikos Health App Sit-to-Stand)

Time frame: From baseline to 3 months

Secondary Outcomes

UPDRS

Change in MDS-UPDRS axial score; Change in MDS-UPDRS Part II

Time frame: From baseline to 3 months

Fall events

Fall events during 3 months

Time frame: From baseline to 3 months

LEDD

Change in LEDD

Time frame: From baseline to 3 months

Central Contacts

Chen-Chih Chung, MD

CONTACT

+886-2-22490088 10670@s.tmu.edu.tw

Chien Tai Hong, MD, PhD

CONTACT

15004@s.tmu.edu.tw

Data from ClinicalTrials.gov

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