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

Taipei Medical University

Status: Not yet enrolling

Conditions: Dementia; Parkinson's Disease (PD)

Treatments: Device: BestShape Go Intelligent Generation Transformable Electric Vehicle

Study type: Interventional

Funder types: Other

Identifiers

NCT07230366

N202510104

Details and patient eligibility

About

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.

Full 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."

Enrollment: 120 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Treatment arm

Experimental group

Description:

Gait abnormalities in patients with neurodegenerative diseases

Treatment:

Device: BestShape Go Intelligent Generation Transformable Electric Vehicle