Post-Stroke Walking Speed and Community Ambulation Conversion, A Pivotal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 15
- 主要终点
- Mean Change in Gait Speed measured by the 10-Meter Walk Test
研究概览
简要总结
The purpose of this randomized, controlled study is to collect performance data on the ability of an investigational device designed to digitally deliver Rhythmic Auditory Stimulation to improve walking speed in people who suffered a stroke greater than six (6) months in the past and who are limited in mobility outside the home. The primary outcomes will be the mean change in walking speed (meters per second) and mean percent change in walking speed as determined by a 10-meter Walk Test after five weeks of intervention and compared between groups.
详细描述
Study participants who take part in this research study will participate in a screening visit, fifteen (15) intervention visits over approximately five weeks and a final closing visit. Study participants will be assigned by chance to one of the two study groups. Participants will not be able to switch groups once they are assigned. The investigational device includes a mobile device app and sensors that are attached to shoes. Headphones and a mobile device are also required to be used and will be provided in this study.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 years of age and older
- •Equal to or greater than six months post-stroke
- •A comfortable walking speed greater or equal to 0.5 meters per second (m/s), but less than 0.8m/s, as determined by a 10-meter walk test.
- •Demonstrates some level of asymmetry in gait
排除标准
- •Has a known history of neurologic (excluding stroke) injury
- •Has had more than 2 falls in the previous month
- •Is enrolled in another walking rehabilitation intervention (e.g., physical therapy)
- •Has an external lower limb prosthetic ("artificial limb")
- •Has a hearing impairment
- •Had orthopedic surgery in the last year
- •Has severe aphasia and/or a speech/language disorder
- •Has co-morbidities that prevent participation in exercise
结局指标
主要结局
Mean Change in Gait Speed measured by the 10-Meter Walk Test
时间窗: Baseline through study completion, an average of six weeks
Mean change in gait speed (meters per second) measured by the 10-Meter Walk Test compared between groups.
Mean Percent Change in Gait Speed measured by the 10-Meter Walk Test
时间窗: Baseline through study completion, an average of six weeks
Mean percent change in gait speed (meters per second) measured by the 10-Meter Walk Test compared between groups.
次要结局
- Community Ambulation Status measured by the 10-Meter Walk Test(At study completion, an average of six weeks)
- Change in Stride Length (meters) as measured by a validated, instrumented walkway system(Baseline through study completion, an average of six weeks)
- Change in Cadence (steps per minute) as measured by a validated, instrumented walkway system(Baseline through study completion, an average of six weeks)
- Change in self-perceived disability as measured by the Stroke Impact Scale (SIS), Version 3.0(Baseline through study completion, an average of six weeks)
- Change in Temporal Symmetry (percent) as measured by a validated, instrumented walkway system(Baseline through study completion, an average of six weeks)
- Change in Spatial Symmetry (percent) as measured by a validated, instrumented walkway system(Baseline through study completion, an average of six weeks)
- Change in Quality of Life as measured by the Stroke-Specific Quality of Life Scale (SS-QOL)(Baseline through study completion, an average of six weeks)