Combining Wearable Robotic Orthosis With Visual and Haptic Feedback to Enhance the Recovery of Upper Extremity Motor Function and ADL in Persons With Acute SCI
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Muscle strength measurement
研究概览
简要总结
This randomized clinical trial (RCT) is evaluating the usefulness of combining MyoMo robotic orthosis with visual and haptic feedback in ameliorating wrist/hand/UE movement capability, and increasing ADL and quality of life in people with acute SCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between the ages of 18-80
- •Be able to activate the muscles of my upper arm and forearm with enough strength as determined by the therapist.
- •Be diagnosed with a spinal cord injury (iSCI (ASIA Impairment Scale (AIS) C and D) and be less than 3 months post initial injury at the start of the study
- •Be medically stable
- •Be able to follow study directions and communicate in English as determined by the study staff
- •Continue to take all prescribed medication (example: baclofen: oral or via pump) without any major dosing changes
- •Be able to tolerate functional tasks for 60min with intermittent rests without excessive fatigue
- •Have full passive range of motion at my elbow, as determined by study staff
排除标准
- •Be younger than 18 years old or older than 80
- •Have excessive pain in my arm or hand that would limit my participation in rehabilitation
- •Have excessive spasticity in my elbow or wrist joints as determined by study staff
- •Be participating in any experimental rehabilitation or drug studies
- •Have a history of neurologic disorder other than spinal cord injury
- •Have other conditions that would prevent safe and/or effective participation using the study device. Examples of these conditions include: severe sensory deficits, skin conditions, joint contractures, etc.
- •Have difficulty following multiple step directions
- •Have severe psychiatric problems or difficulty thinking clearly that would prevent me from participating in this study
- •Have skin issues that would prevent wearing the Myo-Pro device
- •Have had history of recurrent epilepsy, seizure or convulsion
- •Have a past or current history of treated ringing in the ears known as tinnitus or severe hearing problems.
- •Be taking any drugs that would increase my risk of having a seizure while undergoing brain stimulation. Study staff and physician will review my medications to see if I am taking any of these drugs. If I am taking one of these drugs, I will not be enrolled in this study.
- •Because of potential risk to the fetus, women of child-bearing potential will be required to have a pregnancy test before they can enroll in this study. If I am female, and have a positive pregnancy test, I will not be enrolled.
结局指标
主要结局
Muscle strength measurement
时间窗: Approximately 10 weeks
during movements of upper extremities muscle strength is measured using small and light weight surface electromyography sensors which are placed on the participant's skin via double stick tape. Participants will be asked to move their hand and forearm while the muscle strength is measured.
Range of motion of hands and arms
时间窗: Approximately 10 weeks
Movement of upper extremity is measured using small sensors that are able to record joints' angles. These sensors are placed on participant's skin via double sticky tape. Participants will be asked to move their hand and forearm while the elbow, wrist and hand joint angles are measured.
GRASSP
时间窗: Approximately 10 weeks
Assessment of the Hand in Tetraplegia Using the Graded Redefined Assessment of Strength Sensibility and Prehension Upper Extremity Function in Persons with Tetraplegia Relationships Between Strength, Capacity and the Spinal Cord Independence Measure. Total score's minimum and maximum values are between 0 to 116 and higher scores indicate better/improved outcomes.
次要结局
- Brain signals measurement(Approximately 10 weeks)