Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07257393

Fall Risk Assessment in Parkinson's Disease Using Kinetikos Health

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Idiopathic Parkinsonism Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

No Intervention: Observational Cohort

Other

No intervention.

Primary outcomes

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

    Time frame: From baseline to 3 months

Secondary outcomes

  1. UPDRS

    Time frame: From baseline to 3 months

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

  2. Fall events

    Time frame: From baseline to 3 months

    Fall events during 3 months

  3. LEDD

    Time frame: From baseline to 3 months

    Change in LEDD

Study contacts

Contact information is provided by the study sponsor or research team.

Chen-Chih Chung, MD

CONTACT

[email protected]

+886-2-22490088

Chien Tai Hong, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Registry information

Official study title

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

Acronym: PD_FALLRISK

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.