Clinical Validation of AI-powered Smart Vehicle Assisted Gait Training in Neurodegenerative Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Gait speed
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Treatment arm
Gait abnormalities in patients with neurodegenerative diseases
Intervention: BestShape Go Intelligent Generation Transformable Electric Vehicle (Device)
Outcomes
Primary Outcomes
Gait speed
Time Frame: Before & after training (the training sessions will last for 2~12 weeks).
Secondary Outcomes
- 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).)
- 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).)