A Novel Mechanics-based Intervention to Improve Post-stroke Gait Stability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline)
研究概览
简要总结
The purpose of this study is to determine whether a novel treadmill training intervention can improve the gait stabilization strategy used by individuals who have experienced a stroke.
详细描述
Every year, approximately 15,000 American Veterans experience a stroke, with an estimated cost of acute and follow-up care in the hundreds of millions of dollars. Following a stroke, the restoration or improvement of walking is a high-ranking goal among patients, but only about half of the population is able to return to typical levels of community ambulation. The resultant decrease in independent mobility is strongly associated with a decline in quality of life. Gait instability is a common contributor to limited mobility through either an increased fall-risk or fear of falling, but current interventions to address post-stroke gait instability have had limited success. This project will conduct initial testing of a novel elastic force-field designed to improve post-stroke gait stability through targeted motor learning. The results of these experiments will serve as the basis for the development of novel gait rehabilitation techniques, which have the potential to increase the quality of life of thousands of Veterans and save millions of dollars.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 21 years old
- •Experience of a stroke 6 months prior to participation
- •Preferred overground gait speed of at least 0.2 m/s
- •Ability to walk at self-selected speed for 3 minutes without a cane or walker
- •Provision of informed consent.
排除标准
- •Resting heart rate above 110 beats/min
- •Resting blood pressure higher than 200/110 mm Hg
- •History of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
- •Preexisting neurological disorders or dementia
- •History of major head trauma
- •Legal blindness or severe visual impairment
- •Life expectancy <1 yr; 8)
- •History of deep vein thrombosis or pulmonary embolism within 6 months
- •Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
- •Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern.
结局指标
主要结局
Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline)
时间窗: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
A custom measure that quantifies the strength of the relationship between body mechanics and foot placement. This measure falls within a relatively narrow range among neurologically intact controls, but is substantially reduced in some individuals who have experienced a stroke, indicating a reduced ability to stabilize their gait pattern. This measure relates the mechanical state of the body at the start of each step (mediolateral pelvis displacement and velocity of the pelvis relative to the stance foot) to the step width at the end of the step. Specifically, the partial linear correlation between pelvis displacement and step width was calculated, accounting for variation in pelvis velocity. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
次要结局
- Fall Incidence(6 months (during 12 week follow-up period))
- Fear of Falling(6 months (at completion of 12-week Follow-up period))
- 10-meter Walk Test (Change From Baseline)(baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks)
- Functional Gait Assessment (Change From Baseline)(baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks)
- Activities-specific Balance Confidence Scale (Change From Baseline)(baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks)