The Effects of Adding Vibrotactile Feedback to Prostheses on Functional Outcome Measures of Transradial Amputation Prosthetic Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Orthotics and Prosthetics User Survey-Upper Extremity Functional Status
研究概览
简要总结
Investigators wish to evaluate the effects of adding VTF to upper limb prostheses on functional outcome measures of upper limb prosthetic users.
详细描述
Investigators will perform three experiments:
- Investigators will add vibrotactile feedback to prosthetic users during the execution of a standardized functional test and performance of simple grasping tasks, with a disruption to the normal visual feedback, and examine whether their performance and arm kinematics are improved with tactile feedback;
- Investigators will examine the effects of adding the feedback to a prosthesis on the performance and visual attention during a dual task assignment in prosthetic users, and
- Investigators will provide prosthetic users with the feedback, to use it at their natural surroundings for a week, and study the reported activity and satisfaction levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral transradial amputee
- •Using a transradial myoelectric prosthesis
- •Ability to follow simple instructions, understand and sign an informed consent form
- •Normal or corrected eyesight
排除标准
- •Elbow or wrist disarticulation or partial hand amputations
- •Neuropathy or skin ulcers on the amputated limb
研究组 & 干预措施
Vibrotactile feedback
Vibrotactile system - comprises of force sensors, attached to the fingertips of the prosthetic hand, and a set of 8 vibration actuators attached to a fabric arm cuff. When the subject applies force on the sensors with his prosthetic hand, he receives a vibration on the skin of his arm. The sensors and actuators are connected to an electronic control board, which transforms the resistance from the sensors to an electric signal that activates the vibration actuators.
干预措施: Vibrotactile feedback system (Device)
结局指标
主要结局
Orthotics and Prosthetics User Survey-Upper Extremity Functional Status
时间窗: 2 weeks
A subjective questionnaire concerning the ability to perform daily tasks. The score ranges from 23 to 115.
次要结局
- Time to complete dual tasking test(2 weeks)
- Modified Box & Blocks test(2 weeks)
- Activity(2 weeks)
研究者
Isabella Shvartz
Director, clinical research
Hadassah Medical Organization