Fall Risk Assessment in Parkinson's Disease Using Kinetik... | NCT07257393

Studies
Fall Risk Assessment in Parkinson's Disease Using Kinetikos Health

NCT07257393

Sponsor

Taipei Medical University Shuang Ho Hospital

Status

Not yet recruiting

Last Update Posted

Dec 4, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Idiopathic Parkinsonism

Interventions

No Intervention: Observational Cohort

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2025Estimated

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Nov 20, 2025

First Submission Date that Met QC Criteria

Nov 20, 2025

First Posted Date

Dec 2, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2025

Last Update Posted Date

Dec 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
No Intervention: Observational Cohort	Other	No intervention.	Opicapone group Safinamide group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chen-Chih Chung, MD	Contact	+886-2-22490088		10670@s.tmu.edu.tw
Chien Tai Hong, MD, PhD	Contact			15004@s.tmu.edu.tw

Overall Officials

Name	Affiliation	Role
Chen-Chih Chung, MD	Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shuang Ho Hospital, Taipei Medical University		New Taipei City		235	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

No IPD sharing; results published in aggregate

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided