Clinical Validation of AI-powered Smart Vehicle Assisted Gait Training in Neurodegenerative Disorders

December 3, 2025 updated by: Taipei Medical University Shuang Ho Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 235
        • Taipei Medical University Shuang Ho Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with neurodegenerative diseases (such as Parkinson's disease or dementia).
  2. Age between 50-85 years.
  3. Capable of walking for at least 10 meters, but may have unsteady gait or history of falls.
  4. Able to understand the trial procedures and give informed consent.

Exclusion Criteria:

  1. Severe cardiopulmonary disease or recent major surgery.
  2. Unable to walk or requiring comprehensive physical support.
  3. Severe cognitive impairment preventing understanding of the trial procedures or giving informed consent.
  4. Visual or auditory impairments severe enough to prevent following trial instructions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment arm
Gait abnormalities in patients with neurodegenerative diseases
Device: BestShape Go Intelligent Generation Transformable Electric Vehicle
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gait speed
Time Frame: Before & after training (the training sessions will last for 2~12 weeks).
Before & after training (the training sessions will last for 2~12 weeks).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait length
Time Frame: Before & after training (the training sessions will last for 2~12 weeks).
Before & after training (the training sessions will last for 2~12 weeks).
Number of falls
Time Frame: During 2~12 training sessions.
During 2~12 training sessions.
Patients' gait confidence scale
Time Frame: Before & after training (the training sessions will last for 2~12 weeks).
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).
Timed-up-and-Go Test
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).
Clinical Global Impression (CGI)
Before & after training (the training sessions will last for 2~12 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Shuang Ho Hospital

Investigators

  • Principal Investigator: Lung Chan, MD, PhD, Taipei Medical University Shuang Ho Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 2, 2026

Primary Completion (Estimated)

December 10, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

October 2, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Estimated)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N202510104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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