iStride(TM) Device Used for Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Percentage Change in Step Length Asymmetry
研究概览
简要总结
The objective of this research is to test a passive shoe to correct gait in individuals with asymmetric walking patterns. This will be done in a clinic. Individuals with central nervous system damage, such as stroke, often have irregular walking patterns and have difficulty walking correctly. Recent research has shown that using a split-belt treadmill can create after-effects that temporarily correct the inefficient walking patterns. However, the corrected walking pattern does not efficiently transfer from the treadmill to walking over ground. The iStride, formerly known as the Gait Enhancing Mobile Shoe (GEMS), may allow a patient to practice walking in many different locations, such as their own home, which we hypothesize will result in a more permanent transfer of learned gait patterns. To enable long-term use, our proposed shoe design is passive and uses the wearer's natural forces exerted while walking to generate the necessary motions.
详细描述
Hemiparesis and other impairments are a frequent and disabling consequence of stroke and can lead to asymmetric and inefficient walking patterns. Training on a split-belt treadmill, which has two separate treads driving each leg at a different speed, can correct gait asymmetries post-stroke. However, the effects of split-belt treadmill training only partially transfer to everyday walking over ground and extended training sessions are required to achieve long-lasting effects. Our previous studies suggest that the iStride device that has been developed in our laboratory can be used as an alternative gait training device for people with stroke. The iStride device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. The iStride device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. While the movements of the iStride device are similar to the split belt treadmill, and the iStride device generates a similar aftereffect, the efficacy of this shoe in modifying the gait of an individual with stroke is not yet verified.
In this study, we will test the efficacy of the iStride device on individuals with stroke in the clinic. Efficacy will be evaluated based on the change in gait coordination and also based on subjects' self-reported comfort on the device. We predict that the iStride device will result in changes to interlimb coordination of gait that could be a safe and effective device to be used in ones' home.
The asymmetric nature of hemiparetic gait can have a large impact on functional walking ability. For example, swing phase asymmetry is a significant predictor of hemiparetic walking performance because it strongly correlates with stages of motor recovery, walking speed, and falls. Another measure of temporal asymmetry - double support duration - is similarly correlated with walking speed. In addition, spatial (e.g. step length) asymmetry is associated with decreased propulsive force on the paretic leg, which limits forward motion of the body and reduces gait efficiency. The importance of gait efficiency should not be understated - the elevated energy demands of hemiparetic gait combined with physical deconditioning post-stroke can greatly limit performance of activities of daily living, contributing to poor cardiovascular fitness and metabolic syndrome. In turn, this can increase the risks of a second stroke or cardiovascular event and is associated with increased morbidity and mortality rates. Therefore, improving gait symmetry should be an important goal for therapy, to not only improve functional mobility and reduce injury, but also to enhance general health and well-being post-stroke.
Practicing walking on a split-belt treadmill can correct abnormal interlimb coordination of gait in individuals with hemiparesis following stroke or other central nervous system lesions. Asymmetric gait can manifest as a spatial asymmetry, in which steps taken on one side are longer than those on the other. It can also manifest as a temporal asymmetry, where the timing is uneven on the paretic and non-paretic sides. Temporal asymmetries are often measured as differences in the duration of double support periods, which are the amount of time both feet are simultaneously contacting the ground and are measured separately for the paretic and non-paretic sides. The iStride device is designed to cause changes in both spatial and temporal gait symmetry. We predict that the iStride device would cause the steps on the side with the iStride device to be larger since individuals would compensate for the backward rolling motion by placing their foot farther forward in stance, thus increasing the distance between the two feet. Similarly, since the stride is longer, it may also shorten the duration of stance relative to the other side. With shortened stance duration, the amount of time spent in double-support at the end of stance would likely decrease as well.
Although the original idea of the iStride device is derived from the motion of the split-belt-treadmill, there are distinct differences between walking on the device and walking on a split-belt treadmill with asymmetric belt velocities. While the body's velocity relative to ground is zero on a split-belt treadmill, the relative velocity of the iStride device is non-zero and forward. The device forces the wearer's foot forward or backward whereas the treadmill moves both feet backward, but at different speeds. For both the split-belt treadmill and the iStride device, the relative velocity between both feet is similar and the backward-moving iStride device takes the place of the faster tread.
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
- 21 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 21-80
- •one or more cerebral strokes, but all strokes on same side
- •a stroke at least 6 months prior to enrollment
- •Gait asymmetry, but able to walk independently with or without a cane
- •Not currently receiving physical therapy
- •no evidence of severe cognitive impairment that would interfere with understanding the instructions
- •no evidence of one-sided neglect, affecting ambulation
- •At least 25 feet of walking space in home (does not need to be a straight line)
- •Weight does not exceed 250 lbs
排除标准
- •uncontrolled seizures
- •metal implants (stents, clips, pacemaker)
- •pregnancy
- •History of a neurological disorder other than stroke ( Parkinson's, MS)
- •Chronic Obstructive Pulmonary Disease
- •Uncontrolled blood pressure
- •Head injury in the past 90 days
- •A myocardial infarction within the last 180 days
- •Cannot rely on a rolling walker for ambulation
结局指标
主要结局
Percentage Change in Step Length Asymmetry
时间窗: Baseline assessment at start and at conclusion of training
During a symmetric gait, step lengths on each side are the same; during an asymmetric gait, step lengths are different. We will quantify the amount of adaptation and the change in gait asymmetry by comparing the magnitude of step length difference between baseline and after four weeks of training (three training sessions per week). Step length asymmetry is a standard accepted measure for measuring gait asymmetry. To measure the gait, a Gait Up Physilog sensor, a ProtoKinetics Zeno Walkway, or a motion capture system will be used. The analysis will be conducted using a repeated measures ANOVA to compare baseline gait symmetry at the start of the experiment to post-adaptation at the end of the experiment.
Percentage Change in Double Support Asymmetry
时间窗: Baseline assessment at start and at conclusion of training
We will quantify the amount of adaptation and the change in gait asymmetry by comparing the magnitude of double support difference between baseline and after four weeks of training (three training sessions per week). During a symmetric gait, double support is the same; during an asymmetric gait, double support is different. Double support asymmetry is a standard accepted measure for measuring gait asymmetry. To measure the gait, a Gait Up Physilog sensor, a ProtoKinetics Zeno Walkway, or a motion capture system will be used. The analysis will be conducted using a repeated measures ANOVA to compare baseline gait symmetry at the start of the experiment to post-adaptation at the end of the experiment.
次要结局
未报告次要终点
