Ankle Exosuit Training in the Clinic to Community
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in 10 Meter Walk Test from baseline gait speed
研究概览
简要总结
This study focuses on investigating exosuit technology by evaluating its ability to provide a gait-restorative effect delivered in both clinic and community settings. The exosuit provides dynamic dorsiflexion and plantarflexion assist during walking. We will determine the effect of training parameters of intensity, repetition, and gait quality which are all key parameters associated with experience-dependent neuroplasticity. The other objective is to determine the effect of this intervention on community walking activity, walking speed, walking distance, and locomotor mechanics and energetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 80 years old
- •Stroke event occurred at least 6 months ago
- •Observable gait deficits
- •Able to walk without the support of another person for at least 2 minutes (with or without an assistive device or orthotic support)
- •Passive ankle dorsiflexion range of motion to neutral with the knee extended (i.e., able to achieve an angle of 90 degrees between the shank and the foot)
- •Resting heart rate between 40 - 100 bpm, inclusive
- •Resting blood pressure between 90/60 and 170/90 mmHg, inclusive
- •Medical clearance by a physician
排除标准
- •Score of >1 on question 1b and >0 on question 1c on the NIH Stroke Scale
- •Inability to communicate with investigators
- •Neglect or hemianopia
- •Unexplained dizziness in the last 6 months
- •Pressure ulcers or skin wounds located at human-device interface sites
- •History of significant Peripheral Artery Disease (PAD)
- •Unresolved Deep Vein Thrombosis (DVT)
- •Uncontrolled or untreated hypertension
- •Significant paretic ankle contractures (plantarflexion > 5°)
- •Psychiatric or cognitive impairments that may interfere with proper operation of the device
结局指标
主要结局
Change in 10 Meter Walk Test from baseline gait speed
时间窗: Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec).
次要结局
- Functional Gait Assessment (FGA)(Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12)
- Change in 6 Minute Walk Test in distance from baseline(Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12)
研究者
Arun Jayaraman, PT, PhD
Principal Investigator
Shirley Ryan AbilityLab