Improving Ambulation Post Stroke With Robotic Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- 10-meter Walking Test (10mWT)
研究概览
简要总结
The purpose of this research study is to look at a new rehabilitation technique for individuals who have suffered a stroke and have difficulties walking. This study is designed to compare robot-assisted (Lokomat) rehabilitation therapy with standard physical therapy in order to improve walking post-stroke. This research project will be conducted as a pilot randomized controlled trial that compares the effectiveness of Lokomat versus conventional physical therapy in improving the ambulation and gait of chronic stroke patients. The project will provide important pilot data that could indicate whether or not the effectiveness of Lokomat training is superior to that of standard physical therapy and if a definitive and larger clinical trial is warranted.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with ischemic or hemorrhagic stroke confirmed by cerebral computed tomography (CT) or magnetic resonance imaging (MRI) scan
- •At least 3 months post stroke at time of enrollment into study
- •Ability to walk at least 10 feet with maximum 1 person assist, but not to walk in the community independently
- •Residual paresis in the lower extremity as defined by the National Institute of Health Stroke Scale lower extremity motor score 2-4
- •Ability to perform Lokomat ambulation training with assistance of 1 therapist
- •Ability to follow a three-step command
- •Physician approval for patient participation
- •Ability to give informed consent
- •Completed their rehabilitation services, i.e., receiving no concurrent physical, occupational, or speech therapies
排除标准
- •Serious cardiac condition
- •Uncontrolled blood pressure, defined as > 200 or diastolic > 100 at rest
- •Hx of serious chronic obstructive pulmonary disease or oxygen dependence
- •Sever weight bearing pain
- •Lower extremity amputation
- •Claudication while walking
- •Life expectancy < 1 year
- •History of deep vein thrombosis/pulmonary embolism (DVT/PE) within 6 months
- •Severe orthopedic problem
- •Any medical or psychiatric condition that the investigators believe would make the patient unable to participate in this study
结局指标
主要结局
10-meter Walking Test (10mWT)
时间窗: Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention
次要结局
- 6 Minute Walking Distance (6MWD)(Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention)
研究者
Elizabeth Noser
Clinical Assistant Professor - Neurology
The University of Texas Health Science Center, Houston