Menu
Not yet recruiting NCT07257393

Fall Risk Assessment in Parkinson's Disease Using Kinetikos Health

Observational Idiopathic Parkinsonism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention: Observational Cohort.
Who it may be relevant to
Registry conditions: Idiopathic Parkinsonism. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

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.

Interventions

  • Other No Intervention: Observational Cohort
    No intervention.

Primary outcome measures

  • Change in fall-risk index (Kinetikos Health App Sit-to-Stand) [Time frame: From baseline to 3 months]
Secondary outcome measures (3)
  • UPDRS [Time frame: From baseline to 3 months]
  • Fall events [Time frame: From baseline to 3 months]
  • LEDD [Time frame: From baseline to 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Taiwan · 1 center
  • Shuang Ho Hospital, Taipei Medical University — New Taipei City

Identifiers

NCT: NCT07257393 · N202511067

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗