Menu
Not yet recruiting NCT07230366

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

No phase Interventional Parkinson's Disease (PD) Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BestShape Go Intelligent Generation Transformable Electric Vehicle.
Who it may be relevant to
Registry conditions: Parkinson's Disease (PD), Dementia. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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."

Interventions

  • 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.

Primary outcome measures

  • Gait speed [Time frame: Before & after training (the training sessions will last for 2~12 weeks).]
Secondary outcome measures (5)
  • 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).]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Taiwan · 1 center
  • Taipei Medical University Shuang Ho Hospital — New Taipei City

Identifiers

NCT: NCT07230366 · N202510104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗