Idiopathic ParkinsonismPD_FALLRISKNCT07257393
Fall Risk Assessment in Parkinson's Disease Using Kinetikos Health
An observational study of Idiopathic Parkinsonism, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Idiopathic Parkinsonism
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from outpatient neurology clinic, Shuang Ho Hospital, Taipei Medical University
Who may be able to join
- Age ≥20;
- PD diagnosis (MDS criteria);
- On levodopa monotherapy with motor fluctuations;
- Planned to start opicapone or safinamide;
- Consent provided.
Who cannot join
- Atypical/secondary parkinsonism;
- Moderate-severe dementia;
- DBS/MRgFUS/neurosurgery within 6 months;
- Severe comorbidities limiting test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chien Tai Hong, MD, PhD contact
Taiwan1 site
Shuang Ho Hospital, Taipei Medical University
New Taipei City, 235
Chen-Chih Chung, MD, +886-2-22490088, 10670@s.tmu.edu.tw
About this study
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
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.
Read the 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.
- Conditions
- Idiopathic Parkinsonism
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Parkinson's disease, Fall risk, Motor fluctuation, Dopaminergic medication, Mobile health, Sit-to-Stand, Kinetikos Health App
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Opicapone group | PD patients undergo dopaminergic medication adjustments Receives: Other: No Intervention: Observational Cohort | |
| Safinamide group | PD patients undergoing dopaminergic medication adjustments Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fall-risk index (Kinetikos Health App Sit-to-Stand)
Measured: From baseline to 3 months
Secondary outcomes (3)
UPDRS
Change in MDS-UPDRS axial score; Change in MDS-UPDRS Part II
Measured: From baseline to 3 months
Fall events
Fall events during 3 months
Measured: From baseline to 3 months
LEDD
Change in LEDD
Measured: From baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ParkinsonismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen-Chih Chung, MD, Principal investigator, Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257393
- Sponsor's protocol ID
- N202511067
- Acronym
- PD_FALLRISK
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing; results published in aggregate
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07257393
- Acronym / sponsor ID
- PD_FALLRISK / N202511067
- Conditions
- Idiopathic Parkinsonism
- Keywords
- Parkinson's disease, Fall risk, Motor fluctuation, Dopaminergic medication, Mobile health, Sit-to-Stand, Kinetikos Health App
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opicapone group | – | Other: No Intervention: Observational CohortPD patients undergo dopaminergic medication adjustments |
| Safinamide group | – | Other: No Intervention: Observational CohortPD patients undergoing dopaminergic medication adjustments |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from outpatient neurology clinic, Shuang Ho Hospital, Taipei Medical University
Key inclusion criteria (5 listed)
- Age ≥20;
- PD diagnosis (MDS criteria);
- On levodopa monotherapy with motor fluctuations;
- Planned to start opicapone or safinamide;
- Consent provided.
Key exclusion criteria (4 listed)
- Atypical/secondary parkinsonism;
- Moderate-severe dementia;
- DBS/MRgFUS/neurosurgery within 6 months;
- Severe comorbidities limiting test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo intervention. | Other | Opicapone group, Safinamide group |
Primary outcome
Change in fall-risk index (Kinetikos Health App Sit-to-Stand)
Time frame: From baseline to 3 months
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No. No IPD sharing; results published in aggregate
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chien Tai Hong, MD, PhD contact
Chen-Chih Chung, MD principal investigator
Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Parkinsonism, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen-Chih Chung, MD (+886-2-22490088, 10670@s.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fall-risk index (Kinetikos Health App Sit-to-Stand) (time frame: From baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.