AMES Treatment of the Impaired Leg in Chronic Stroke Patients
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Motor Assessment of the Lower Affected Extremity
研究概览
简要总结
The purpose of this protocol is to determine if individuals who had a stroke more than one year before entering the study and whose ankles remain substantially impaired are able to sense and move the affected leg better after 9-13 weeks of treatment with a robotic therapy device (AMES).
详细描述
Our research objective is to develop procedures to rehabilitate those stroke patients who, through conventional therapies, are not brought to a level of maximal recovery. The aims of the proposed project are to obtain a set of data from a total of 20 chronic stroke subjects, all with severe lower extremity disability, between the ages of 18-85, using a robotic therapeutic device placed in a rehabilitation clinic. This data will allow us to quantify the extent to which a combination of robotic-assisted exercise and tendon vibration from the AMES beta device induces secondary recovery from the effects of stroke on the lower extremity.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spastic hemiparesis
- •At least 12 months post-stroke
- •Can comfortably fit foot in treatment device
- •Functioning proprioception
- •Fugl-Meyer LE score >6 and <23
- •Minimal hemi-neglect
- •Observable volitional movement of the ankle in either plantar- or dorsi-flexion
- •Cognitively and behaviorally capable of complying with the regimen
排除标准
- •Fractures of treated limb resulting in loss of range of motion
- •Spinal cord injury
- •Deep venous thrombosis
- •Peripheral nerve injury or neuropathy in the affected limb with motor disability
- •Osteoarthritis limiting range of motion
- •Uncontrolled high blood pressure/angina
- •Exercise intolerant
- •Skin condition not tolerant of device
- •Progressive neurodegenerative disorder
- •Uncontrolled seizure disorder
- •Botox treatment within last 5 months
- •Baclofen pump
研究组 & 干预措施
AMES Leg treatment
An investigational device flexes and extends the ankle over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the foot. The subject's task is to assist the motion of the device by pulling or pushing with the foot. Feedback of ankle torque or the electrical signal produced by the muscles (EMG) while the subject is assisting the motion is provided during the 30 treatment sessions.
干预措施: AMES- Leg treatment (Device)
结局指标
主要结局
Fugl-Meyer Motor Assessment of the Lower Affected Extremity
时间窗: Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
次要结局
- Ankle Strength(Prior to each treatment session,)
- Gait Assessment(Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments)
- Modified Ashworth Scale(Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments)
- Dynamic Balance/Weight Distribution(Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments)
- Passive Motion Test(Prior to each treatment session)
- Active Range of Motion Test(Prior to each treatment session)