Clinic-Based Ames Treatment of the Lower Extremity in Chronic Stroke Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment of the Lower Extremity
研究概览
简要总结
This study investigates whether assisted movement with biofeedback and muscle vibration applied to the lower limb reduces impairment and improves gait.
详细描述
The hypothesis of this study is that chronic stroke survivors, more than one year post-stroke, with a motor problems in the lower extremity will be able to walk and move the affected leg better after 30 treatments with a new robotic therapy device, the AMES device. The device rotates the ankle while vibrators stimulate the tendons attached to muscles that move the ankle. Testing will be done before, during and after the treatments to determine response to the therapy.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 12 months post-stroke
- •Cognitively and behaviorally capable of complying with the regimen
- •Functioning proprioception
- •Less than 50% of normal strength in the affected ankle, but able to stand with or without assistive devices
排除标准
- •Fractures of treated limb resulting in loss of range of motion
- •Spinal cord injury
- •Deep vein thrombosis
- •Peripheral nerve injury or neuropathy in the limb affected with motor disability
- •Osteoarthritis limiting range of motion
- •Skin condition not tolerant of device
- •Progressive neurodegenerative disorder
- •Uncontrolled seizure disorder
- •Botox treatment within the last 5 months
- •Baclofen pump
结局指标
主要结局
Fugl-Meyer Assessment of the Lower Extremity
时间窗: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
Gold standard for motor impairment in individuals with stroke. A scale measuring tone, range-of-motion and synergies of the lower limb with a range of 0-34, higher scores referring to improved motor ability. The assessment includes 7 subscales, the scores of which are summed to arrive at a total score.
次要结局
- Stroke Impact Scale(Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up)
- Spasticity (Modified Ashworth) Scale(Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up)
- Timed 10-Meter Walk(Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up)
- Strength Test(First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10))
- Active Motion Test(First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10))
研究者
Paul J. Cordo
Principal Investigator
Oregon Health and Science University