Assisting Stroke Survivors With Engineering Technology (ASSET): Design Project D3: Exoskeletal Networks for Forearm Supination
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Action Research Arm Test (ARAT)
研究概览
简要总结
The purpose of this study is to evaluate the safety, feasibility, and efficacy of an exoskeletal network of passive, multi-joint springs for forearm supination. Also known as the forearm ExoNET, the device is a passive, robotic device that will properly assist forearm supination in the post-stroke adult population.
详细描述
The ExoNET, a passive robotic solution that provides a soft, biomimetic, and elastic alternative to robotics that embodies intelligence within the mechanical design. Several groups have been exploring performance enhancement using springs with custom-tuned parameters via optimization. Here, it is possible to have a simple reconfigurable system that can not only assist performance, but can also make training easier, faster, and more complete. This contribution has the potential to be clinically significant for rehabilitating neurologically impaired individuals because this proposal will investigate how motor learning can be facilitated through novel assistive technology.
The primary objective of this study is to evaluate the safety, feasibility, and efficacy of using the forearm ExoNET. Specifically, investigators would like to see if the forearm ExoNET tuned to assistance will lead to a reduction in forearm muscle activity and an increase in active supination range of motion. To accomplish this, we plan to have participants perform upper extremity activities of daily living requiring active forearm supination wearing the ExoNET. To achieve these goals, we will use a wearable surface electromyography (EMG) and inertial measurement unit (IMU) using Delsys wearable sensors on the forearm muscles.
Investigators hypothesize that individuals with post-stroke arm movement deficits will experience gains in Action Research Arm Test (ARAT) measures that are significantly above their baseline levels while using the forearm ExoNET tuned to supination assistive support. Secondarily, investigators hypothesize that a forearm ExoNET tuned to supination assistive support will lead to a significant reduction in arm muscle activity and no significant difference in range of motion across a series of upper-extremity tasks in adults without a history of stroke. Lastly, it is hypothesized that usage of a forearm ExoNET tuned to supination anti-assistance can be safe, feasible and tolerated by patients in a given treatment session.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 40-70 (to reduce confounding effects of aging on muscle, movement accuracy and proprioception)
- •Have sustained a single, unilateral stroke at least 8 months prior to enrollment
- •Severe to moderate upper extremity impairment (ARAT score 0-30)
- •Ability to move their elbow and wrist when supported against gravity
- •Cortical stroke with hemiparesis, tactile sensation
- •Available medical records about lesion locations indicating the stroke was caused by a middle cerebral artery ischemic infarct
排除标准
- •Bilateral paresis
- •Diffuse/multiple lesion sites or multiple stroke events
- •Hemispatial neglect or visual field cut that prevent visual feedback
- •Shoulder pain and/or articular rigidity on the upper limb joint
- •Severe sensory deficits indicated by the Two-Point Discrimination Test
- •Botox injection to the affected upper extremity within the previous 4 months
- •Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to consent, perform the experiment, or follow commands
- •Concurrent participation in upper extremity rehabilitation either as part of a research intervention protocol or a prescribed therapy
- •Other neurological issues
- •Meet any of the contraindications to Delsys Trigno Sensors:
- •Implanted with electronic devices of any kind, including cardiac pace-makers or similar assistive devices, electronic induction pumps, and implanted stimulators
- •Irritated skin or open wounds
- •Silver allergy
结局指标
主要结局
Action Research Arm Test (ARAT)
时间窗: Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)
Observational measure used to assess change in upper extremity performance in individuals with a damaged nervous system
次要结局
- Upper extremity portion of the Fugl-Meyer (FMUE)(Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation))
- Box and Blocks(Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation))
研究者
James Lanphier Patton
Co-Director, Robotics Laboratory, Arms and Hands Lab, Shirley Ryan AbilityLab
Shirley Ryan AbilityLab