Safety and Performance Assessment of the LIFT System When Used to Support Home-based Upper Extremity Training in Individuals With Spinal Cord Injury.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 10
- 主要终点
- Incidence of all adverse events (AEs)
研究概览
简要总结
The LIFT Home Study is an observational, single-arm study designed to assess the safety of non-invasive electrical spinal stimulation (ARC Therapy) administered by the LIFT System to treat upper extremity functional deficits in people with chronic tetraplegia.
详细描述
The primary goal of this study is to report on the safety of the study device when used at home. In addition, the study will report on observed changes in upper extremity function and strength after a period of home use.
The LIFT Home Study will enroll subjects who have recently completed participation in the Up-LIFT Study. The study includes a set of baseline assessments to be completed in the clinic, a four-week home use treatment program prescribed by the investigator, and a final set of clinic-based assessments at the end of the study.
At the baseline visit, the subject and caregiver will be trained on the use of the device and prescribed a specific training regime for its use at home. The subject will be issued a device that is uniquely programmed to operate within a limited set of parameters as specified by the investigator.
Throughout the study, subjects will be prompted to report all adverse events (AE) regardless of relatedness to the device.
At baseline and the final clinic visit, UE strength and function will be measured with stimulation off using a comprehensive set of assessment tools including CUE-T, GRASSP, Pinch and Grasp Force, as well as patient and caregiver global impression of change questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 22 years old and no older than 75 years old at the time of enrollment
- •Non-progressive cervical spinal cord injury from C2-C8 inclusive
- •American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D
- •Indicated for upper extremity training procedures by subject's treating physician, occupational therapist or physical therapist
- •Minimum 12 months post-injury
- •Capable of providing informed consent
- •Completed the Up-LIFT Study within the prior 12 months
排除标准
- •Has uncontrolled cardiopulmonary disease or cardiac symptoms as determined by the Investigator
- •Has any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations like severe neuropathic pain, depression, mood disorders or other cognitive disorders
- •Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled
- •Requires ventilator support
- •Has an autoimmune etiology of spinal cord dysfunction/injury
- •Spasms that limit the ability of the subjects to participate in the study training as determined by the Investigator
- •Breakdown in skin area that will come into contact with electrodes
- •Has any active implanted medical device
- •Pregnant, planning to become pregnant or currently breastfeeding
- •Concurrent participation in another drug or device trial that may interfere with this study
- •In the opinion of the investigators, the study is not safe or appropriate for the participant
结局指标
主要结局
Incidence of all adverse events (AEs)
时间窗: Through completion of the study, an average of 6 months
Observational data regarding the incidence of all adverse events related to the use of the study device and treatment procedures will be reported.
次要结局
- Extended use of the LIFT System at home(Through completion of the study, an average of 6 months)