Portable Ankle Robotics to Reverse Foot Drop After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Number of Heel-First Foot Strikes
研究概览
简要总结
The randomized study (in Phase II of the U44) compares the efficacy and durability of 9 weeks (18 sessions) of robot-assisted physical therapy (PTR) versus physical therapy (PT) alone on foot drop as assessed by gait biomechanics (ankle angle at initial contact, peak swing ankle angle, number of heel-first strikes - % total steps, gait velocity) and blinded clinician assessment (dorsiflexion active range of motion, ankle muscle strength, assistive device needs).
详细描述
This proposal investigates a portable ankle robot (AMBLE) to be used during over-ground mobility training to reduce foot drop and improve walking function in hemiparetic (half-body, partially paralyzed stroke patients with foot drop (inability to properly lift and clear the foot during walking. About 30% of stroke survivors are left with permanent ankle weakness that impairs their mobility and increases fall-risk. Currently, stroke survivors with foot drop live with a cane or other assistive device, and often ankle-foot braces (AFOs) for safety. These assistive devices do not reverse or reduce the underlying neurological foot drop problem. Recognizing the crucial role of ankle function in walking and balance, and recognizing that the distal part of the lower extremity often suffers the greatest damage after a human stroke, the investigators have come up with a portable ankle robot as a tool for therapists to help shape recovery of walking.
The AMBLE, and its underlying control system, uses information about how patients are walking from one step to another to assist and shape foot lifting so as to help re- train walking recovery by a process that neuroscientists call motor learning. It is the combination of the partially paralyzed stroke survivor's movement efforts with timely assistance "only as needed" by the robot that investigators and others show is the key to movement recovery after stroke. Thus, the ankle robot is not a crutch, but a learning and measuring device that incrementally "gets out of the way" of the learner to facilitate human robot learning such that the human takes over more of the volitional learning.
The research team at University of Maryland has demonstrated in 4 prior studies using seated and treadmill based robot assisted training using a bulky laboratory robot programmed with a motor learning formula that can improve ankle motor control in both the early and chronic phases of stroke, and this can improve over-ground unassisted walking. A significant proportion of stroke survivors showed session by session recovery of volitional (not assisted by the robot) ankle lifting during walking across 6 weeks of three 30- 45 minute sessions of robot training while walking on a treadmill, even years after their stroke. In fact, it has been found that two weeks of 3 sessions per week ankle robotics training was the time profile for most motor learning recovery to reduce foot drop. This information has informed the design of the study described below.
Previous research was done using a bulky, heavy (~8 lbs), and expensive laboratory robot that only allowed seated or treadmill based training because it was tethered by wires. This greatly limits how it can be used by physical therapists, and is not appropriately configured for ease of use by physical therapists in practice. NextStep Robotics invented and built the ankle robots motor learning programs with a lot of input from physical therapists and other rehabilitation clinicians into a portable lightweight robot that can be used over-ground anywhere with blue tooth controls that also tell the therapist precisely how well the stroke survivors is learning, step by step. It is this new portable ankle robot that is configured for use in practice that investigators seek to test in studies with physical therapists using it fully integrated into their usual outpatient stroke mobility recovery training at University of Maryland Orthopedics and Rehabilitation Institute.
This U44 Award from the National Institute of Neurological Disorders and Stroke (NINDS) is not a typical single phase randomized clinical study, but consists of Phase I that completes commercial design of the robot the first year, followed by Phase II randomized clinical trial across years 2-4 of a finalized commercial version of the ankle robot.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 and older
- •In the subacute phase of stroke recovery (>6 weeks to <6 months post-stroke) with residual hemiparesis of the lower extremity that includes symptoms of foot-drop. - or - In the chronic phase of stroke recovery (>6 months post-stroke) with residual hemiparesis of the lower extremity that includes symptoms of foot-drop.
- •Clear indications of hemiparetic gait by clinical observation
排除标准
- •Cardiac history of (a) unstable angina, (b) recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II); (c) hemodynamically significant valvular dysfunction
- •Hypertension that is a contraindication for routine physical therapy (greater than 160/100 on two assessments).
- •Medical History: (a) recent hospitalization (less than 3 months) for severe medical disease, (b) symptomatic peripheral arterial occlusive disease, (c) orthopedic or chronic pain conditions that significantly alter gait function, (d) pulmonary or renal failure (e) active cancer
- •History of non-stroke neuromuscular disorder restricting gait.
- •Aphasia or cognitive functioning that confounds participation, defined as unable to follow 2 step commands or judgment of the medical officer or therapist.
结局指标
主要结局
Number of Heel-First Foot Strikes
时间窗: Change from Baseline at both 9 Weeks and at 21 Weeks
Number of heel-first foot strikes for each subject at a given testing time point.
Angle at Initial Contact
时间窗: Change from Baseline at both 9 Weeks and at 21 Weeks
Angle at initial contact averaged across each gait cycle for each subject at a given testing time point.
Swing Dorsiflexion
时间窗: Change from Baseline at both 9 Weeks and at 21 Weeks
Peak swing dorsiflexion averaged across each gait cycle for each subject at a given testing time point.
Gait Velocity
时间窗: Change from Baseline at both 9 Weeks and at 21 Weeks
Average gait velocity (meters/second) for each subject at a given testing time point.
次要结局
- Active range of motion for Dorsiflexion(Change from Baseline at both 9 Weeks and at 21 Weeks)
- Ankle Muscle Strength(Change from Baseline at both 9 Weeks and at 21 Weeks)
- Stroke Impact Scale(Change from Baseline at both 9 Weeks and at 21 Weeks)
- Activities-Specific Balance Confidence Scale(Change from Baseline at both 9 Weeks and at 21 Weeks)
- Dynamic Gait Index(Change from Baseline at both 9 Weeks and at 21 Weeks)
- Berg Balance Scale(Change from Baseline at both 9 Weeks and at 21 Weeks)
- CES-D (Center for Epidemiological Studies-Depression)(Change from Baseline at both 9 Weeks and at 21 Weeks)
- Modified Ashworth Scale(Change from Baseline at both 9 Weeks and at 21 Weeks)
- Number of Participants Using Assistive Devices and Ankle Foot Orthoses(Change from Baseline at both 9 Weeks and at 21 Weeks)
- NIH Stroke Scale(Change from Baseline at both 9 Weeks and at 21 Weeks)
- Falls Efficacy Scale(Change from Baseline at both 9 Weeks and at 21 Weeks)
- Fatigue Assessment Scale(Change from Baseline at both 9 Weeks and at 21 Weeks)