NCT04800926已完成不适用
Xavier Electromyographic Wheelchair Control for Limited Mobility Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Wheelchair Skills Test (WST)
研究概览
简要总结
The purpose of this study is to assess the functional mobility and self-reported satisfaction with the Xavier electromyography hands-free wheelchair control system in comparison with a standard joystick.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ALS diagnosis by revised el Escorial criteria (definite, probable or probable laboratory supported)
- •Age 18-89
- •Limited mobility with use of motorized wheelchair at screening-time
- •Impairment of hand function limiting the use of a standard joystick control
- •Caregiver willing to assist with transfers into wheelchair and application of controllers
- •Ability to attend study visits with a motorized wheelchair
- •Ability to communicate and answer patient reported outcome measure questions
排除标准
- •Cognitive impairment prohibiting safe independent mobility as defined by an ALS-Cognitive Behavioral Screen (ALS-CBS) score of <10 or the opinion of the investigator
- •A sensory impairment prohibiting safe independent mobility in the opinion of the investigator
- •Allergy to adhesives or electrode gels (required for EMG electrodes)
- •Skin breakdown over the temporalis muscle that would predispose to further breakdown and/or infection with electrodes
- •Severe loss of facial muscle functionality or control that would preclude EMG electrode efficacy
- •Subjects who do not have the capacity to consent
结局指标
主要结局
Wheelchair Skills Test (WST)
时间窗: approximately 3 days
Questionnaire
次要结局
- Drive test(approximately 3 days)
研究者
Bjorn E. Oskarsson
Principal Investigator
Mayo Clinic
研究点 (2)
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