Health TrialsbyHealthPanel

Fall Risk Assessment in Parkinson's Disease Using Kinetikos Health

ConditionIdiopathic Parkinsonism
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorTaipei Medical University Shuang Ho Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥20;

PD diagnosis (MDS criteria);

On levodopa monotherapy with motor fluctuations;

Planned to start opicapone or safinamide;

Disqualifiers

Atypical/secondary parkinsonism;

Moderate-severe dementia;

DBS/MRgFUS/neurosurgery within 6 months;

Severe comorbidities limiting test

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No Intervention: Observational Cohort

    Other intervention

    No intervention.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Opicapone group1 intervention
Group B: Safinamide group1 intervention

Trial outcomes

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

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

Time frame
From baseline to 3 months
2

Fall events

Fall events during 3 months

Time frame
From baseline to 3 months
3

LEDD

Change in LEDD

Time frame
From baseline to 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taipei Medical University Shuang Ho Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: