Soft Exosuits for Functional Gait Recovery in Acute Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in 10 Meter Walk Test
研究概览
简要总结
The purpose of this study is to develop and evaluate the use of soft exosuits in patients post stroke.
详细描述
AIM 1: Develop individualized adaptive controller parameters and a training progression program for these exosuits specific for inpatient stroke rehabilitation.
AIM 2: Evaluate the impact of the soft exosuit + conventional inpatient rehabilitation vs.
conventional inpatient rehabilitation alone on measures of lower-extremity impairments and functional recovery following acute stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years
- •History of single stroke event with deficits predominately affecting one side of the body
- •Stroke less than 4 years ago (AIM 1)
- •Stroke within the past 6 months (AIM 2)
- •Capable of standing with assistance
- •Medical clearance by a physician
排除标准
- •Inability to communicate with investigators
- •Pressure ulcers or skin wounds located where the exosuit interfaces (calf, thigh, waist)
- •History of significant peripheral artery disease (PAD)
- •Unresolved deep vein thrombosis (DVT)
- •Psychiatric or cognitive impairments that may interfere with proper operation of the device
- •Known urethane allergies
- •Pregnancy
- •Other comorbidities that prevent full participation in research
研究组 & 干预措施
AIM 1: Single Group (Hip Flexion Soft Exosuit)
For AIM 1, all participants are assigned to the training group using a hip flexion soft exosuit. During the training/tuning sessions, individuals will perform up to 60 minutes of walking with the exosuit on the treadmill, overground or completing stairs, with rest breaks as needed. Goals during these sessions are to modify and update the controllers for the exosuit to appropriately provide assistance to the patient while ambulating in collaboration with Harvard University. We may also test clinical training progressions with the exosuit during walking training. Some part of the session may include walking with the exosuit assisting and other part of the session may include without the device assisting for comparison. Total session time for each session may be up to 2 hours, and up to 8 training/tuning visits will be performed.
干预措施: Hip flexion soft exosuit (Device)
AIM 2: Device Group (ReWalk ReStore Soft Exosuit)
For participants in the experimental group, these exosuits will be utilized in up to all physical therapy sessions during the course of the patient's inpatient stay. With the consideration that an inpatient stay may be up to 10 weeks, total number of sessions may be up to 75 visits. Sessions will vary from 30-90 minutes depending on inpatient therapy scheduling.
干预措施: ReWalk ReStore soft exosuit (Device)
AIM 2: Control Group
Participants in the control group will participate in conventional physical therapy without use of exosuits during the course of the patient's inpatient stay. With the consideration that an inpatient stay may be up to 10 weeks, total number of sessions may be up to 75 visits. Sessions will vary from 30-90 minutes depending on inpatient therapy scheduling.
干预措施: Conventional physical therapy (Other)
结局指标
主要结局
Change in 10 Meter Walk Test
时间窗: Admission time-point to discharge time-point (estimated 2-4 weeks). Pre-assessment completed after admission to inpatient rehabilitation, prior to first intervention session. Post-assessment completed following last treatment session, prior to discharge.
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). The data table shows the change in gait speed (meters per second) from admission to discharge, time frame varies based on length of stay (estimated 2-4 weeks).
次要结局
未报告次要终点
研究者
Arun Jayaraman, PT, PhD
Director, Max Nader Center for Rehabilitation Technologies & Outcomes Research
Shirley Ryan AbilityLab