Fall Risk Assessment in Parkinson's Disease Using Kinetikos Health

NCT07257393 | Not Yet Recruiting

• 1 other identifier: N202511067
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Idiopathic Parkinsonism

Keywords

Parkinson's disease; Fall risk; Motor fluctuation; Dopaminergic medication; Mobile health; Sit-to-Stand; Kinetikos Health App

Outcome Measures

Primary Outcomes (1)

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

  From baseline to 3 months

Secondary Outcomes (3)

• UPDRS

  From baseline to 3 months

• Fall events

  From baseline to 3 months

• LEDD

  From baseline to 3 months

Study Arms (2)

Opicapone group

PD patients undergo dopaminergic medication adjustments

Other: No Intervention: Observational Cohort

Safinamide group

PD patients undergoing dopaminergic medication adjustments

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No intervention.

Opicapone group; Safinamide group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from outpatient neurology clinic, Shuang Ho Hospital, Taipei Medical University

You may qualify if:

• Age ≥20;
• PD diagnosis (MDS criteria);
• On levodopa monotherapy with motor fluctuations;
• Planned to start opicapone or safinamide;
• Consent provided.

You may not qualify if:

• Atypical/secondary parkinsonism;
• Moderate-severe dementia;
• DBS/MRgFUS/neurosurgery within 6 months;
• Severe comorbidities limiting test

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Shuang Ho Hospital, Taipei Medical University

New Taipei City, 235, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Chen-Chih Chung, MD

  Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)