Parkinson's Disease (PD)NCT07230366
Clinical Validation of AI-powered Smart Vehicle Assisted Gait Training in Neurodegenerative Disorders
A study of Parkinson's Disease (PD) and Dementia, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
This study aims to verify the safety and preliminary clinical benefits of long-term gait training using AI-powered smart electric vehicles for patients with neurodegenerative diseases such as Parkinson's disease and dementia. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinson's Disease (PD), Dementia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Jan 2026to 31 Dec 2028
- Phase
- Interventional
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with neurodegenerative diseases (such as Parkinson's disease or dementia).
- Age between 50-85 years.
- Capable of walking for at least 10 meters, but may have unsteady gait or history of falls.
- Able to understand the trial procedures and give informed consent.
Who cannot join
- Severe cardiopulmonary disease or recent major surgery.
- Unable to walk or requiring comprehensive physical support.
- Severe cognitive impairment preventing understanding of the trial procedures or giving informed consent.
- Visual or auditory impairments severe enough to prevent following trial instructions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Likai Huang, MD contact
Taiwan1 site
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235
Chien Tai Hong, MD, PhD, +886 970747668, 15004@s.tmu.edu.tw
About this study
This study aims to verify the safety and preliminary clinical benefits of long-term gait training using AI-powered smart electric vehicles for patients with neurodegenerative diseases such as Parkinson's disease and dementia.
Read the detailed description
This study is a single-center, prospective, open-label clinical intervention trial aimed at verifying the clinical safety and preliminary efficacy of an AI-powered smart electric vehicle in gait training for patients with Parkinson's disease and dementia. It is expected to recruit 120 participants aged 50-85 years, who will be randomly assigned to different training durations (2~12 weeks), with training sessions conducted two or three times a week, each lasting 30 to 60 minutes. The primary assessment indicators include gait speed, number of falls, and gait confidence scale, while secondary assessments include satisfaction and balance function. All study data will be coded and preserved for 10 years. The study is funded by the "Healthy Taiwan Cultivation Plan."
- Conditions
- Parkinson's Disease (PD), Dementia
- Being tested
- BestShape Go Intelligent Generation Transformable Electric Vehicle
- Keywords
- Neurodegenerative Diseases, Smart Electric Vehicles, Gait Training
- Medical subject headings
- Parkinson Disease, Dementia, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BestShape Go Intelligent Generation Transformable Electric VehicleDevice
The specific applications of artificial intelligence in intelligent electric vehicles mainly include gait monitoring and analysis, real-time feedback and guidance, autonomous adaptive assistance, safety prevention and warnings, data collection and longterm tracking, as well as adding interactive and entertainment elements.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Gait abnormalities in patients with neurodegenerative diseases Receives: Device: BestShape Go Intelligent Generation Transformable Electric Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
Measured: Before & after training (the training sessions will last for 2~12 weeks).
Secondary outcomes (5)
Gait length
Measured: Before & after training (the training sessions will last for 2~12 weeks).
Number of falls
Measured: During 2~12 training sessions.
Patients' gait confidence scale
Measured: Before & after training (the training sessions will last for 2~12 weeks).
Patients' balance function
Timed-up-and-Go Test
Measured: Before & after training (the training sessions will last for 2~12 weeks).
Patients' feedback
Clinical Global Impression (CGI)
Measured: Before & after training (the training sessions will last for 2~12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start2 Jan 2026 (estimated)
- Primary completion10 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lung Chan, MD, PhD, Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230366
- Sponsor's protocol ID
- N202510104
- Status last verified
- Sep 2025
- First submitted
- 2 Oct 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of AI-powered Smart Vehicle Assisted Gait Training in Neurodegenerative Disorders
- ClinicalTrials.gov ID
- NCT07230366
- Acronym / sponsor ID
- N202510104
- Conditions
- Parkinson's Disease (PD), Dementia
- Keywords
- Neurodegenerative Diseases, Smart Electric Vehicles, Gait Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 2 Jan 2026 (estimated)
- Primary completion
- 10 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Nov 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 study aims to verify the safety and preliminary clinical benefits of long-term gait training using AI-powered smart electric vehicles for patients with neurodegenerative diseases such as Parkinson's disease and dementia.
Detailed description
This study is a single-center, prospective, open-label clinical intervention trial aimed at verifying the clinical safety and preliminary efficacy of an AI-powered smart electric vehicle in gait training for patients with Parkinson's disease and dementia. It is expected to recruit 120 participants aged 50-85 years, who will be randomly assigned to different training durations (2~12 weeks), with training sessions conducted two or three times a week, each lasting 30 to 60 minutes. The primary assessment indicators include gait speed, number of falls, and gait confidence scale, while secondary assessments include satisfaction and balance function. All study data will be coded and preserved for 10 years. The study is funded by the "Healthy Taiwan Cultivation Plan."
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: BestShape Go Intelligent Generation Transformable Electric VehicleGait abnormalities in patients with neurodegenerative diseases |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with neurodegenerative diseases (such as Parkinson's disease or dementia).
- Age between 50-85 years.
- Capable of walking for at least 10 meters, but may have unsteady gait or history of falls.
- Able to understand the trial procedures and give informed consent.
Key exclusion criteria (4 listed)
- Severe cardiopulmonary disease or recent major surgery.
- Unable to walk or requiring comprehensive physical support.
- Severe cognitive impairment preventing understanding of the trial procedures or giving informed consent.
- Visual or auditory impairments severe enough to prevent following trial instructions.
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 |
|---|---|---|
| BestShape Go Intelligent Generation Transformable Electric VehicleThe specific applications of artificial intelligence in intelligent electric vehicles mainly include gait monitoring and analysis, real-time feedback and guidance, autonomous adaptive assistance, safety prevention and warnings, data collection and longterm tracking, as well as adding interactive and entertainment elements. | Device | Treatment arm |
Primary outcome
Gait speed
Time frame: Before & after training (the training sessions will last for 2~12 weeks).
5 secondary outcomes
Gait length
Time frame: Before & after training (the training sessions will last for 2~12 weeks).
Number of falls
Time frame: During 2~12 training sessions.
Patients' gait confidence scale
Time frame: Before & after training (the training sessions will last for 2~12 weeks).
Patients' balance function
Time frame: Before & after training (the training sessions will last for 2~12 weeks).
Patients' feedback
Time frame: Before & after training (the training sessions will last for 2~12 weeks).
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 10 Dec 2025.
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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.
Likai Huang, MD contact
Lung Chan, MD, PhD principal investigator
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Parkinson's Disease (PD) and Dementia, 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 4 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 10 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 Chien Tai Hong, MD, PhD (+886 970747668, 15004@s.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed (time frame: Before & after training (the training sessions will last for 2~12 weeks).). 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 10 Dec 2025.