Clinical Validation of AI-powered Smart Vehicle Assisted Gait Training in Neurodegenerative Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Gait speed
研究概览
简要总结
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.
详细描述
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."
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment arm
Gait abnormalities in patients with neurodegenerative diseases
干预措施: BestShape Go Intelligent Generation Transformable Electric Vehicle (Device)
结局指标
主要结局
Gait speed
时间窗: Before & after training (the training sessions will last for 2~12 weeks).
次要结局
- 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).)