NCT03054064已完成不适用
Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 7
- 主要终点
- Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the Indego exoskeleton as a gait training tool for individuals with hemiplegia due to Cerebrovascular Accident (CVA).
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
- •Height 5'1" to 6'3" (acceptable height may vary by a few inches depending on femur length)
- •Weight 250 pounds or less
- •History of one sided ischemic or hemorrhagic stroke with resultant hemiparesis
- •Manual Muscle Test (MMT) 4/5 in at least upper extremity
- •No restrictions on time since stroke (acuity), but all subjects need to be cleared by MD for locomotor training
- •No other brain abnormalities or neurological diseases/disorders
- •Has not been diagnosed with more than one stroke
- •Passive range of motion (PROM) at shoulders, trunk, hips, knees and ankles within functional limits for safe gait
- •Skin intact where interfaces with Indego device
- •Modified Ashworth Scale (MAS) for spasticity 3 or less in the lower extremities
- •Absence of complicating physical or mental conditions as determined by MD that would preclude the individual from safely participating in gait training
- •Must be able to follow directions and communicate basic needs, demonstrated by a Mini- Mental State Exam (MMSE) score of 18 or greater
排除标准
- •Failure to meet all inclusion criteria
- •Pregnancy
- •Colostomy bag
- •Uncontrolled/untreated hyper- or hypotension
研究组 & 干预措施
All Enrolled Subjects
Experimental
All enrolled subjects will receive gait training with the Indego.
干预措施: Indego Exoskeleton (Device)
结局指标
主要结局
Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events
时间窗: 2 weeks
Safety of individuals with hemiplegia due to CVA using the Indego measured through reported Subject Adverse Events and Serious Adverse Events
次要结局
- Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale(2 weeks)
- Pain Measured With Face, Legs, Activity, Cry, Consolability Scale(2 weeks)
- Activity Measured by Functional Ambulation Category(2 weeks)
- Gait Speed (Without Indego) Measured With 10 Meter Walk Test(2 weeks)
研究者
研究点 (7)
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