Evaluating Error Augmentation for Neurorehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Arm motor recovery scores on the Fugl-Meyer
研究概览
简要总结
This is a sub-project of a larger NIDRR Grant. One promising form of robotic training that leverages the power of neuro-plasticity is error augmentation. In this paradigm the computer singles out and magnifies a stroke survivor's movement errors from a desired trajectory, thus forcing the subjects to strengthen their control. Using the VRROOM, a state-of-the-art system which uses haptics (robotic forces) and graphics (visual display) interfaces, a subject's desired trajectory can be determined and the movement errors can be amplified in real-time with dramatic results. This project evaluates a practical approach of error augmentation, using therapist-driven trajectories. The investigators intend to determine clinical efficacy of several types of therapist-assisted error augmentation on retraining the nervous system in functional activities. The investigators will test two experimental treatments in a crossover design. The investigators hypothesize that combined haptic and visual error augmentation will lead to the best functional recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult (age >18)
- •survived a single cortical stroke at least 6 months previously involving ischemia or hemorrhage of the middle cerebral artery (MCA),
- •demonstrated the presence of some active shoulder and elbow movement (characterized by Fugl-Meyer Assessment Upper Extremity scores ranging from 15-50 for ARM 1; 25-50 for ARM 2).
排除标准
- •diffuse or multiple lesion sites or multiple stroke events
- •bilateral paresis
- •severe spasticity or contracture (Modified Ashworth ≥3
- •severe concurrent medical problems
- •severe sensory deficits
- •cerebellar strokes resulting in severe ataxia
- •significant shoulder pain
- •focal tone management with Botulinim Toxin (Botox®) injection to the hemiparetic upper extremity (UE) within the previous four months,
- •aphasia that would influence the ability to perform the experiment
- •cognitive impairment (Mini Mental State Examination < 23/30)
- •affective dysfunction that would influence the ability to perform the experiment
- •depth perception impairment (< 3 on Stereo Circle Test)
- •visual field cut or hemispatial neglect that would influence the ability to participate in the activity
- •inability to provide informed consent
结局指标
主要结局
Arm motor recovery scores on the Fugl-Meyer
时间窗: Change from baseline in Fugl-Meyer to 11 weeks (with assessment periods occurring at 2 weeks, 3 weeks, 4 weeks, 6 weeks, 7 weeks, and 11 weeks for ARM 1; at start of week 1 (pre-eval), end of week 2 (post), and end of week 3 (1 week follow-up) for ARM 2)
Change from baseline in arm motor recovery as measured by Fugl-Meyer
次要结局
- Number of blocks transferred in Box and Blocks Test(same as primary)
- Time and Quality of movement scores on the Wolf Motor Function Test(same as primary)
- Time scores and Ability scores on the Assessment of Simple Functional Reach Test(same as primary (not used for ARM 2))
- Quantity and Quality with Motor Activity Log(same as primary but added for ARM 2)
研究者
James Patton
Co-Director, Robotics Laboratory, Sensory Motor Performance Program, Rehabilitation Institute of Chicago
Shirley Ryan AbilityLab