Fall Risk Assessment in Parkinson's Disease Using Kinetikos Health (PD_FALLRISK)

Taipei Medical University

Status: Not yet enrolling

Conditions: Idiopathic Parkinsonism

Treatments: Other: No Intervention: Observational Cohort

Study type: Observational

Funder types: Other

Identifiers

NCT07257393

N202511067

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Opicapone group

Description:

PD patients undergo dopaminergic medication adjustments

Treatment:

Other: No Intervention: Observational Cohort

Safinamide group

Description:

PD patients undergoing dopaminergic medication adjustments

Treatment:

Other: No Intervention: Observational Cohort