NCT03175055已完成不适用
Phoenix Exoskeleton Clinical Study
US Bionics7 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2017年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Timed Up and Go (TUG)
研究概览
简要总结
This study will evaluate the Phoenix device for safety and effectiveness at allowing persons with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •18 Years of age or older in general good health
- •Weigh no more than 220lbs
- •Skin must be healthy where it touches the Phoenix
- •Able to stand using a device such as a standing frame
- •Have enough strength in your hands and shoulders to support yourself standing and walking using crutches or a walker
- •Have good control of upper body
- •Determined to have enough bone health to walk full weight bearing without risk of fracture. Meeting of this condition is at the discretion of your personal MD
- •Passive range of motion (PROM) at shoulders, trunk, upper extremities and lower extremities within functional limits for safe gait and use of appropriate assistive device/stability aid
- •Hip width no greater than 18" (46 cm) measured when sitting.
- •Femur length between 12.3 inches (31.3 cm) and 19.8 inches (50.2 cm) measured between centers of hip and knee joints.
- •Tibia length between 13.4 inches (33.9 cm) and 22 (55.9 cm) inches measured between the knee joint and bottom of the foot.
- •In general good health and able to tolerate moderate levels of activity.
- •Blood pressure and heart rate within established guidelines for locomotive training:
- •At rest; Systolic 150 or less Diastolic 90 or less and Heart rate 100 or less Exercise; Systolic 180 or less Diastolic 105 or less and Heart Rate 145 or less
排除标准
- •Pregnant or lactating females
- •Spinal cord injury level higher than T4
- •Severe muscle stiffness/tightness
- •Significant spasticity (Modified Ashworth Scale score of 3 or above)
- •Trunk or lower extremity pressure ulcer
- •Open Wounds
- •Unstable spine, un-healed limbs, or fractures
- •Severe sensitivity to touch
- •Presence of bone in soft tissue where bone normally does not exist (heterotopic ossification), limiting range of motion in the hip or knee joints
- •Joint instability, dislocation, moderate to severe hip dysplasia
- •Significant scoliosis (>40 degrees)
- •Hardware, implant, or any external device impeding with safe fitting or use of Phoenix
- •Femoral or tibial rotation deformity (>15 degrees)
- •Significant flexion contractures limited to 35º at the hip and 20º at the knee
- •Uncontrolled seizures, musculoskeletal injury, fracture or lower-limb surgery in past year.
- •Known history of pulmonary disease limiting exercise tolerance or history of cardiac disease
- •Psychopathology, or other condition that the physician or investigator, in his or her clinical judgment, considers to be exclusionary to safely use an exoskeleton.
- •Severe concurrent medical diseases, illness, systemic or peripheral infection
- •Dizziness or headache with standing
- •History of autonomic dysreflexia
- •Orthostatic Hypotension: Decrease in Systolic BP > 20, Diastolic BP > 10 upon standing from a seated position.
研究组 & 干预措施
Phoenix
Experimental
Phoenix
干预措施: Phoenix (Device)
结局指标
主要结局
Timed Up and Go (TUG)
时间窗: 10 weeks
10 Meter Walk Test (10MWT)
时间窗: 10 weeks
6 Minute Walk Test (6MWT)
时间窗: 10 weeks
次要结局
- Surface Walk Test(10 weeks)
研究者
研究点 (7)
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