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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-02

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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

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Parkinson's Disease (PD) Dementia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Treatment arm

Gait abnormalities in patients with neurodegenerative diseases

Group Type EXPERIMENTAL

BestShape Go Intelligent Generation Transformable Electric Vehicle

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No