6Degrees VR System for Treatment of Phantom Limb Pain
试验速览
- 阶段
- 不适用
- 发起方
- 6Degrees LTD
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Pain change
研究概览
简要总结
The treatment system consists of two light-weight MyMove bands and virtual-reality gear. Built-in software allows tracking of performance in real-time, with feedback to both the patient and treating personnel.
MyMove is a wearable device that allows patients with loss of upper-limb function to operate computers, cellular phones, and similar devices. The technology is non-invasive and does not involve risk to the patient.
MyMove+ is a Physical Medicine and Rehabilitation software intended for use in upper extremity and full-body conventional rehabilitation by:
- Tracking motion and movement kinematics.
- Guiding patients in the performance of physical exercises according to the treating practitioner's guidelines.
MyMove+ software is not intended for use in diagnosis, treatment or decision-making, or as a stand-alone device.
详细描述
A non-blinded controlled study of adults, ages 18-65, with unilateral, below-knee limb amputation.
All subjects will be initially evaluated by a single group of licensed physical- and occupational therapists. Following a structured introductory session, subjects will be assigned to MyMove devices and VR gear for a total of 10 sessions over a period of 5 weeks (15-20 minutes per session).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clearance by the treating physician.
- •Unilateral below-knee amputation
- •History of phantom-limb pain with an intensity of 5-or-greater (VAS scale)
- •Pain is not responsive to conventional drugs or other standard treatment.
- •Range of motion (knee) of 10-to-90 degrees.
排除标准
- •Bilateral amputation
- •History of phantom-limb pain with an intensity of 4-or-less (VAS scale)
- •No prior attempt at therapy
- •Declined by patient
- •Pregnancy or other limitation related to special health-care groups.
结局指标
主要结局
Pain change
时间窗: 12 months
Demonstrate non-inferiority in comparison with existing treatments - change pain level by at least two visual analog scale (VAS) levels. VAS scale runs from 0 (pain-free) to 10 (extreme pain).
次要结局
- Physical Rehabilitation Recovery(12 months)