Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis
试验速览
- 阶段
- 不适用
- 发起方
- Myomo
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Modified Ashworth Scale
研究概览
简要总结
The objective of this study is to evaluate the functional benefits of a myoelectric Elbow-Wrist-Hand orthosis for persons with upper limb paralysis caused by a cerebrovascular accident (CVA).
详细描述
The objective of this study is to evaluate the functional gains provided by a myoelectric Elbow-Wrist-Hand orthosis for CVA patients with hemiparesis. The subjects will be fit with the device, provided general training in the operation of the EMG-controlled technology, and then guided through a series of standard clinical outcome measures used routinely as part of stroke rehabilitation medicine. The outcome measures employed in this study include the Fugl-Meyer assessment, the Box and Blocks test, and a battery of common functional tasks and activities. These outcome measures will allow the researchers to approximate the changes in the subjects' ability to successfully perform functional tasks with and without the MyoPro device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 18 years.
- •Upper limb impairment caused by any stroke (CVA)
- •Minimum of trace MMT (1/5) in Biceps and/or Triceps
- •Full Passive range of motion in elbow, forearm, wrist, and hand
- •Active shoulder flexion of at least 30 degrees of shoulder abduction of at least 20 degrees
- •Score of at least 20 on the Mini Mental Status Examination.
- •Ability to read and comprehend the English language.
- •Ability to generate consistent, detectable EMG signal from the upper arm and forearm sensor sites with wrist in neutral or flexed positions.
排除标准
- •Fixed upper limb contractures on affected side.
- •Subjects with severe spasticity or tone (defined as 3 or more on the Modified Ashworth Scale).
- •Inability to follow three step directions.
- •Severe shoulder subluxation, pain or shoulder dislocation.
- •Passive shoulder range of motion less than 45 degrees in flexion and abduction.
- •Pain or hypersensitivity in the arm(s)
结局指标
主要结局
Modified Ashworth Scale
时间窗: 2 hours
Measurement of muscle spasticity due to nervous system injury or disease http://www.rehabmeasures.org/Lists/RehabMeasures/PrintView.aspx?ID=902
Box and Blocks Test
时间窗: 2 hours
An assessment of unilateral gross manual dexterity, measured by the number 1 inch cubes an individual can move over a barrier in a 60 second time period. http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=917
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
时间窗: 2 hours
Assessment of sensorimotor function for the upper extremities (arms) http://www.rehabmeasures.org/lists/rehabmeasures/dispform.aspx?ID=908
次要结局
未报告次要终点