NCT01251549已完成不适用
Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Safety of use
研究概览
简要总结
ReWalk suit developed by Argo Medical Technologies is designed to enable people with lower limb disabilities to carry out routine ambulatory functions (stand, walk etc.); it can be used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple sclerosis, cerebral palsy and other pathologies that produce severe walking impairments.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complete cervical (C7-8) or thoracic (T1-T12) spinal cord injury according to American Spinal Injury Association (ASIA) guidelines
- •Male and non-pregnant non-lactating female Age 18-55
- •At least 6 months after injury
- •Regular use of RGO (Reciprocating Gait Orthosis) or KAFO's (Knee Ankle Foot Orthoses) or able to stand using a standing device (e.g., 'Easy stand')
- •Patients must be capable of providing informed consent
- •Height of 160 to 190 cm
- •Weight of <100 kg
排除标准
- •History of severe neurological injuries other than SCI (Spinal Cord Injuries)(MS (Multiple Sclerosis), CP (Cerebral Palsy), ALS (Amyotrophic Lateral Sclerosis) , TBI (Traumatic Brain Injury) etc)
- •Severe concurrent medical diseases: infections, circulatory, heart or lung, pressure sores
- •Severe spasticity (Ashworth 4) or uncontrolled clonus
- •Unstable spine or unhealed limbs or pelvic fractures
- •Heterotopic ossification
- •Significant contractures
- •Psychiatric or cognitive situations that may interfere with the trial
结局指标
主要结局
Safety of use
时间窗: 3 months
Number of participants with related adverse events as a Measure of Safety and Tolerability
次要结局
- Efficacy(3 months)
研究者
研究点 (3)
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