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

NCT07230366 | Not Yet Recruiting

• 1 other identifier: N202510104
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dementia; Parkinson's Disease (PD)

Keywords

Neurodegenerative Diseases, Smart Electric Vehicles, Gait Training

Outcome Measures

Primary Outcomes (1)

• Gait speed

  Before & after training (the training sessions will last for 2~12 weeks).

Secondary Outcomes (5)

• 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

  Before & after training (the training sessions will last for 2~12 weeks).

• Patients' balance function

  Before & after training (the training sessions will last for 2~12 weeks).

• Patients' feedback

  Before & after training (the training sessions will last for 2~12 weeks).

Study Arms (1)

Treatment arm

EXPERIMENTAL

Gait abnormalities in patients with neurodegenerative diseases

Device: BestShape Go Intelligent Generation Transformable Electric Vehicle

Interventions

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.

Treatment arm

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical University Shuang Ho Hospital

New Taipei City, 235, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease; Dementia; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lung Chan, MD, PhD

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien Tai Hong, MD, PhD

CONTACT

+886 970747668; 15004@s.tmu.edu.tw

Likai Huang, MD

CONTACT

greatoriole@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: November 17, 2025
• Study Start: January 2, 2026
• Primary Completion (Estimated): December 10, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-09

Locations

TW (1)