Evaluation of the Safety and Performance of the NESS L300 Plus System
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bioness Inc
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Occurence of anticipated and unanticipated adverse events
研究概览
简要总结
The study is designed to evaluate the safety and efficacy of using the L300 Plus as a neuroprosthesis device for walking in patients following an UMN injury or disease. The clinical study is proposed to determine the anticipated adverse event rate and treatment outcomes at the conclusion of the study.
详细描述
This is a prospective, one-center, single group, repeated measures, non inferiority study. Forty-five (45) subjects suffering from foot drop and thigh muscles weakness due to upper motor neuron injury or disease will be evaluated for this study. Each subject will be in the study for six weeks. Clinical benefits will be measured through an assessment of the gait performance. In particular it will test the hypothesis that the NESS L300 Plus System which involves foot drop correction with thigh muscles activation, may achieve walking enhancements not inferior to those gained from using a system that only corrects foot drop (i.e. NESS L300).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Upper motor neuron lesion
- •Thigh muscle weakness - hamstrings or quadriceps strength of less than 4/5 according to manual muscle testing
- •Foot drop - toe drag during walking
- •Lower limb spasticity - 0-4 according to the modified Ashworth scale
- •Responsible mental state, able to follow multiple step directions
- •Between 18 and 80 years old
- •Available for participation in the study
- •Able to understand and sign the informed consent form
- •Able to walk independently or with an assistance device (e.g. cane, walker etc.) / spot guarding for at least 10 meters
- •Sufficient response to electrical stimulation (visible muscle contractions in a seated or prone position of each designated muscle separately)
排除标准
- •Subjects with a demand-type cardiac pacemaker, defibrillator or any electrical or metallic implant
- •Cancerous lesion of lower limb, present or suspected
- •Medical condition that prevents participation or would likely lead to inability to comply with the protocol [e.g.: congestive heart failure, patient receiving chemotherapy, uncontrolled epilepsy, etc]
- •Severe cognitive impairment (MMSE<21)
- •Severe neglect (Star cancellation test<30)
- •Skin lesion at the site of the stimulation electrodes
- •Change in bone-joint structures of the lower limb, such as contractures or deformations; fracture or dislocation, which would be adversely affected by motion from the stimulation
- •Pregnancy
- •Diagnosis of major depression or psychotic disorder
- •Participation in another investigation that may directly or indirectly affect the study results
- •Unable to tolerate electrical stimulation
结局指标
主要结局
Occurence of anticipated and unanticipated adverse events
时间窗: Throughout the 6 weeks of the study
The occurence of anticipated and unanticipated events will be documented at each scheduled evaluation. In addition, subjects will be instructed to report adverse events 24 hours per day during the study period.
Subject feedback regarding the safety of using the device
时间窗: Week 6
Patient feedback regarding the safety of using the device as reported during the study sessions and the completion of a satisfaction questionnaire will also be used to assess the system's safety.
次要结局
- Temporal Gait Parameters of the 2 Minute Walk Test(Week 1 and Week 6)
- 10 Meter Obstacle Course Walking Velocity(Week 1 and Week 6)