NCT00820638Unknown1 期
Myomo NeuroRobotic System Home Safety Study For Use by Stroke Survivors for Upper Extremity Rehabilitation in Their Homes
适应症
试验速览
- 阶段
- 1 期
- 发起方
- Myomo
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- No reported adverse events
研究概览
简要总结
Up to 25 subjects will use the Myomoe100 in the home setting under the distant supervision of an occupational therapist. We will look to see if they can perform functional activities safely without adverse events.
详细描述
Hypothesis Subjects can safely use the Myomo e100 NeuroRobotic System in the home.
Primary Outcome Measures:
-
Safety:
-
Safety of the device will be measured by the number of unanticipated or significant device related adverse events reported over a three week period of time. Minor known risks anticipated from device use are mild muscle soreness and fatigue. These will not be considered adverse events.
Secondary objectives & outcome measures:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •A current medical history of uncontrolled cardiovascular, or pulmonary disease, or other disease that would preclude involvement in a therapeutic treatment - Subjects must be able to tolerate a 45 minute upper-extremity therapy session in order to participate.
- •History of neurological disorder other than stroke- other neurological disorders may affect the upper extremity motor performance of subjects.
- •Other significant pain or skin irritation in the upper extremity that would be exacerbated if by the use of the brace - While wearing the brace, the system is pressed close to the upper arm and strapped around it. If the subject suffers from dermal breakdown or other skin conditions that may be aggravated by such a situation, they should not be involved in the study.
- •Substantial contracture of elbow - The system cannot work in the presence of reduced range of motion due to contractures. A substantial contracture is defined as greater than 20 degrees of elbow flexion contracture measured at the baseline evaluation.
- •Severe sensory loss: Score of 2 on the NIH stroke scale for sensory impairment. The system can work on subjects with sensory loss, however the concern is that a subject with severe sensory loss would not know if the system was applying too much force to the arm or if a strap was too tight and therefore not be able to inform their clinician.
- •Use of Botox injections in shoulder, arm or hand for the 3 months prior to study start and throughout the duration of the research study. - the use of Botox may alter the subject's performance on upper extremity motor tasks that are being assessed in the research
- •Cognitive or perceptual deficits sufficiently severe enough to interfere with ability to follow instructions- If the subject is unable to understand and follow simple instructions or express if the presence of pain, they should not be included. If the subject scores <69 on the Modified Mini Mental Exam or, if in the opinion of the principle investigator the subject can not safely participate in the study, the subject will be excluded.
结局指标
主要结局
No reported adverse events
时间窗: 3 weeks of home use
次要结局
未报告次要终点
研究者
研究点 (2)
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