AMES Rehabilitation of the Proximal Arm in Severely Impaired Stroke Patients
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment - Upper Extremity
研究概览
简要总结
Subjects will receive 30 treatments with AMES, to the proximal arm which has been affected by a chronic stroke.
详细描述
This study seeks to determine whether 30 treatments with AMES, to the proximal affected arm of subjects with chronic stroke, will improve subjects' proximal arm active range-of-motion. We hypothesize that the combination of assisted movement, torque biofeedback, and muscle vibration will reduce impairment (i.e., increase strength and range-of-motion; decrease inappropriate patterns of muscle contraction) and, thereby, lead to more accurate reaching with the proximal arm.
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
- •Ischemic or Hemorrhagic stroke affecting the right arm
- •One year or longer since stroke
- •Severe impairment of right arm with a baseline upper extremity Fugl-Meyer score between 8-24
- •Right elbow and shoulder spasticity (Ashworth score ≤3)
- •Right shoulder abduction-elbow flexion dyssynergia
排除标准
- •Exercise intolerance
- •Co-morbidities limiting arm movement (e.g. shoulder subluxation)
- •Chronic pain
- •Cognitive dysfunction preventing compliance with instructions
- •Participation in other ongoing research studies
- •Plans to initiate or discontinue any physical/occupational therapy during the period of enrollment
研究组 & 干预措施
PAAD (Proximal Arm AMES Device)Treatments
The PAAD flexes and extends the elbow, and it abducts and adducts the shoulder, where "abduction" is away from the side of the body, and "adduction" is towards it. Elbow extension occurs simultaneously with shoulder abduction, and elbow flexion occurs simultaneously with shoulder adduction. At the same time as the movements, vibrators are utilized to activate muscle spindle Ia receptors in the muscles of the arm to exaggerate the perception of movement.
干预措施: 30 PAAD treatments (Device)
结局指标
主要结局
Fugl-Meyer Assessment - Upper Extremity
时间窗: Baseline and change from baseline at 0 and 3 months post completion
次要结局
- Modified Wolf Motor Test(Baseline and change from baseline at 0 and 3 months post completion)
- Ashworth Spasticity Scale(Baseline and change from baseline at 0 and 3 months post completion)
研究者
Paul J. Cordo
Sub-Investigator
Oregon Health and Science University