Long-Term, Prospective, Non-Interventional Study Monitoring Safety and Training in Patients With Spinal Cord Injuries and Their Trained Companions Recently Initiated With the ReWalk™ Personal Device
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Long-term safety of the ReWalk Personal Device for Subjects in institutional and non- institutional environments, as measured by 12-month incidence of all Serious Adverse Events in Subjects
研究概览
简要总结
This study seeks to further evaluate the Multi-Tiered Training Program and to further explore the overall safety profile of the ReWalk Personal Device outside of the institutional setting under conditions of routine medical practice.
详细描述
This study will monitor and further describe the long-term safety of the ReWalk Personal Device for Subjects and their Companions in institutional and non-institutional environments, such as the clinic, home, and community. The study will also evaluate the adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, their Companions, and their Clinical Trainers, monitor and further describe all ReWalk Personal Device malfunctions and screen for potential Unexpected Adverse Events.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For use in institutional and non-institutional environments: Subjects with spinal cord injury at levels T7 to L
- •Age ≥ 18 years old;
- •Hands and shoulders can support crutches or a walker;
- •Healthy bone density;
- •Skeleton does not suffer from any fractures;
- •Able to stand using a device such as EasyStand;
- •In general good health;
- •Height is between 160 cm and 190 cm (5'3" - 6'2");
- •Weight does not exceed 100 kg (220 lbs);
- •Proficiency in spoken and written English language.
排除标准
- •History of severe neurological injuries or disease other than SCI (MS, CP, ALS, TBI, etc.);
- •Severe concurrent medical disease, including infections, circulatory, heart or lung, pressure sores;
- •Severe spasticity (Ashworth 4)
- •Uncontrolled clonus;
- •Unstable spine or unhealed limbs or pelvic fractures;
- •Heterotopic ossification;
- •Significant contractures;
- •Psychiatric or cognitive situations that may interfere with proper operation of the device or participation in this study;
- •Pregnancy
结局指标
主要结局
Long-term safety of the ReWalk Personal Device for Subjects in institutional and non- institutional environments, as measured by 12-month incidence of all Serious Adverse Events in Subjects
时间窗: 12 Months
Long-term safety of the ReWalk Personal Device for Companions in institutional and non-institutional environments, as measured by 12-month incidence of all Serious Adverse Events in Companions
时间窗: 12 Months
Long-term safety of the ReWalk Personal Device for Subjects in institutional and non- institutional environments, as measured by 12-month incidence of falls and fall- associated injuries
时间窗: 12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, as measured by the proportion of Subjects enrolled in training who successfully complete the intended training
时间窗: 12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, as measured by the Subjects' abilities to navigate surfaces and environments outside of the institutional environment in accordance with their training
时间窗: 12 Months
Adequacy of the ReWalk Training Program for Subjects, measured by the proportion of Subjects who successfully completed the intended training who are able to demonstrate proficiencies at 12 months after completion of the intended training
时间窗: 12 Months
Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Companions, as measured by the proportion of Companions enrolled in training who successfully complete the intended training
时间窗: 12 Months
次要结局
- Reliability of the ReWalk Personal Device, as measured by the rates of all device malfunctions(12 Months)
- Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Companions, as measured by the qualitative Prescribing Physician, Clinical Trainer, Companion, and Subject responses to directed and open-ended questioning(12 Months)
- Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Clinical Trainers, as measured by the qualitative Clinical Trainer responses to directed and open-ended questioning(12 Months)
- Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, as measured by the qualitative Prescribing Physician, Clinical Trainer, Companion, and Subject responses to directed and open-ended questioning(12 Months)