Customizable Cooperative Multi-joint Control to Enhance Walking Mobility After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Difference in Gait speed
研究概览
简要总结
This is a device study that will evaluate the effect of an implanted stimulator on improving walking in stroke survivors. There are two phases in the study: 1) Screening - this phase determines if the individual is a good candidate to receive an implanted system, 2) Implantation, controller development, and evaluation - this phase includes installing the device and setting the individual up for home use, creating advanced controllers for walking and evaluating the effect of the device over several months.
详细描述
The purpose of this study is to evaluate the effects of neural stimulation for improving walking after stroke. Participants will undergo surgery to implant a stimulator and electrodes to activate muscles used during walking. The device delivers electrical pulses to the nerves causing the muscles to contract to perform functional movements. The system coordinates assistance based on external sensors. After receiving the implanted device, participants undergo training to use the device to assist walking. Evaluations are completed prior to surgery as well after training and at later follow up sessions.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 6-months post stroke
- •Age 21 to 75 years old
- •Able to ambulate, but does not require the assistance of more than one person
- •Walk slower than 0.8m/s during a 10m walk test
- •Lower extremity Fugl-Meyer Motor Assessment (FMA) <= 20
- •Reduced peak hip, knee and/or ankle range of motion during stance or swing phases
- •Modified Ashworth Scale (MAS) <= 2 at the above joints during passive flexion and extension
- •Innervated and excitable lower extremity and trunk musculature
- •Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
- •Adequate social support and stability
- •Willingness to comply with follow-up procedures
- •Neurologically stable as determined by a physician
排除标准
- •Non-English speaking
- •Significant range of motion limitations (lacking hip extension, etc.)
- •History of spontaneous fractures or other evidence of excessively low bone density
- •Acute orthopedic problems (severe scoliosis, joint dislocations, etc.)
- •Medical complications (cardiac abnormalities, skin breakdowns, uncontrolled seizures, immunological/pulmonary/renal/circulatory compromise, additional neurologic conditions etc.)
- •Cardiovascular or pulmonary disease
- •Uncontrolled diabetes or hypertension
- •Presence of a demand pacemaker or cardiac defibrillator
- •Pregnancy
- •Complications of stroke that result in an increased risk of falls (apraxia, uncompensated hemineglect, hemianopsia etc.)
- •Significant history of repeated falls
- •Severely impaired cognition and communication
- •Any other medical or psychological condition that would be a contraindication
研究组 & 干预措施
Implantation, controller development, and evaluation
This phase includes installing the device and setting the individual up for home use, creating advanced controllers for walking and evaluating the effect of the device over several months.
干预措施: IST 12 & IST 16 (Device)
Implantation, controller development, and evaluation
This phase includes installing the device and setting the individual up for home use, creating advanced controllers for walking and evaluating the effect of the device over several months.
干预措施: IRS-8 (Device)
结局指标
主要结局
Difference in Gait speed
时间窗: baseline, ~18 weeks post implant, ~44 week post implant
The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance. Gait speed is how we're evaluating whether the advanced controller works better than a simple generic triggering approach.
次要结局
- Difference in Usability Rating Scale (URS)(baseline, ~18 weeks post implant, ~44-week post implant)
研究者
Nathaniel Makowski
Assistant Professor
MetroHealth Medical Center