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

December 3, 2025 updated by: Taipei Medical University Shuang Ho Hospital

Validation of a Mobile Health Application for Fall Risk Assessment in Parkinson's Disease: A Comparative Study Before and After Dopaminergic Medication Adjustment

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 235
        • Shuang Ho Hospital, Taipei Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Opicapone group
PD patients undergo dopaminergic medication adjustments
Other: No Intervention: Observational Cohort
No intervention.
Safinamide group
PD patients undergoing dopaminergic medication adjustments
Other: No Intervention: Observational Cohort
No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in fall-risk index (Kinetikos Health App Sit-to-Stand)
Time Frame: From baseline to 3 months
From baseline to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UPDRS
Time Frame: From baseline to 3 months
Change in MDS-UPDRS axial score; Change in MDS-UPDRS Part II
From baseline to 3 months
Fall events
Time Frame: From baseline to 3 months
Fall events during 3 months
From baseline to 3 months
LEDD
Time Frame: From baseline to 3 months
Change in LEDD
From baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Shuang Ho Hospital

Investigators

  • Principal Investigator: Chen-Chih Chung, MD, Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Estimated)

December 2, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N202511067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD sharing; results published in aggregate

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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