Evaluating Wearable Robotic Assistance on Gait Mechanics and Energetics in Individuals With Neurological Impairment
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in Walking Speed
研究概览
简要总结
The overarching goal of this study is to improve mobility in individuals with movement disorders through advances in wearable assistance (i.e. powered orthoses).
详细描述
Individuals with cerebral palsy completed high frequency over-ground gait training (4x/week for 1 week) with ankle exoskeleton assistance, and then, after a 1 year washout period, the same participants will complete low frequency over-ground gait training (2x/week for 2 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 5 and 35 years old, inclusive.
- •Either a healthy volunteer or a diagnosis of a neurologically-based walking disorder due to stroke, spinal cord injury, Parkinson's disease, or cerebral palsy.
- •Must be able to understand and follow simple directions based on parent report and clinical observation during the history and physical examination.
- •Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used.
- •The ability to read and understand English.
- •Able to walk at least 30 feet with or without a walking aid (GMFCS Level I-III for individuals with cerebral palsy)
排除标准
- •Any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis other than stroke, spinal cord injury, Parkinson's disease or cerebral palsy that would affect the ability to walk as directed for short periods of time.
结局指标
主要结局
Change in Walking Speed
时间窗: Measured at the pre (day 1) and post (day 4) gait training assessments
The change in the walking speed will be measured over-ground using a stop watch. Units: % change between post vs pre assessments
The Metabolic Energy Required to Walk
时间窗: Measured at the pre (day 1) and post (day 4) gait training assessments
The change in the metabolic energy required to walk will be measured using a portable metabolic measurement system (Cosmed K5). Units: change in % difference post vs pre gait training.
次要结局
- Change in Muscle Activity Variance Ratio(Measured at the pre (day 1) and post (day 4) gait training assessments)
- Change in Cadence(Measured at the pre (day 1) and post (day 4) gait training assessments)
- Change in Stride Length(Measured at the pre (day 1) and post (day 4) gait training assessments)
研究者
Zachary Lerner
Principal Investigator
Northern Arizona University