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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.
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."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Gait abnormalities in patients with neurodegenerative diseases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BestShape Go Intelligent Generation Transformable Electric Vehicle | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gait speed | Before & after training (the training sessions will last for 2~12 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Gait length | Before & after training (the training sessions will last for 2~12 weeks). | |
| Number of falls | During 2~12 training sessions. | |
| Patients' gait confidence scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chien Tai Hong, MD, PhD | Contact | +886 970747668 | 15004@s.tmu.edu.tw | |
| Likai Huang, MD | Contact | greatoriole@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lung Chan, MD, PhD | Taipei Medical University Shuang Ho Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Shuang Ho Hospital | New Taipei City | 235 | Taiwan |
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|
| Before & after training (the training sessions will last for 2~12 weeks). |
| Patients' balance function | Timed-up-and-Go Test | Before & after training (the training sessions will last for 2~12 weeks). |
| Patients' feedback | Clinical Global Impression (CGI) | Before & after training (the training sessions will last for 2~12 weeks). |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003704 | Dementia |
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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