Restoration of Daily-life Hand Function Using a Brain/Neural-Computer Interaction (BNCI) System in Paralysis After Cervical Spinal Cord Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change of Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) Score
研究概览
简要总结
In this study, 6 volunteer participants with chronic spinal cord injury will be invited to use an autonomous hand exoskeleton device controlled by a brain/neural-computer interaction (BNCI) system fusing electroencephalography (EEG) and electrooculography (EOG) to detect the intention of the user to grasp objects of daily life. The BNCI system consists of a lightweight hand exoskeleton connected to portable motors, rechargeable batteries and a computerized control system integrated into a wheelchair. Before, during and after use of the BNCI system the volunteers will perform standardized assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton. Functional outcomes primarily focus on motor function in performing daily life actions while psychological outcomes primarily focus on safety, reliability as well as predisposition and perceptions of disability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B & C (Lower Extremity Motor Score <20)
- •Motor level of injury from cervical level 4 to cervical level 7, according to ASIA guidelines
- •Male and non-pregnant, non-lactating female
- •Age 15-65 years old
- •At least 12 months after injury
排除标准
- •History of severe neurological injuries other than spinal cord injury (e.g. Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke)
- •Concurrent medical diseases (eg. infections, circulatory, heart or lung, pressure sores) interfering with the study
- •Unstable spine or unhealed limbs or pelvic fractures
- •Severe spasticity (Ashworth grade 4; ie. Affected part(s) rigid in flexion or extension) or uncontrolled clonus
- •Diagnosis of severe osteoporosis/penia as proven with pQCT or DXA.
- •Psychiatric or cognitive conditions that may interfere with the trial
- •Patients incapable of providing informed consent
结局指标
主要结局
Change of Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) Score
时间窗: Hand function will be assessed twice on the same day. Once before the hand exoskeleton is applied (absence of the assistive device) and once after the brain-controlled hand exoskeleton was attached to the patients' hand and arm.
The TRI-HFT will be applied once before and while the patients wear the hand exoskeleton
次要结局
未报告次要终点