Assessing Force Feedback With the SoftHand Pro (CUFF)
2020年11月18日 更新者：Kristin Zhao, PhD
Assessing the Effectiveness of Upper-limb Force Feedback With the SoftHand Pro Myoelectric Prosthesis in Persons With Transradial Limb Loss
The trial is designed to test the effectiveness of a force-feedback cuff in combination with a myoelectric prosthesis in conveying information on grasp strength to the user, as well as the user's preference regarding the feature.
研究概览
详细说明
The human sensorimotor control system uses both feedforward planning and sensory feedback information, in order to actuate the musculoskeletal system and interact with the external environment, e.g. when modulating grip force for various object properties.
As a result, lack of sensory input, as in the case of motor impairments or amputations, can dramatically affect activities of daily living (ADLs).
The contribution of the proposed research will be to test the effectiveness of a novel, non-invasive prosthetic technology in delivering sensory information.
The investigators' approach is "modality matching," in that it produces a sensation in the user similar to the type of information to be transmitted.
Specifically, the approach will combine the Soft Hand Pro (SHP), an anthropomorphic, myoelectrically controlled prosthetic hand, with an upper limb force feedback device (CUFF) to provide patients with transradial amputations with grasp force (pressure) information.
研究类型
介入性
注册 (实际的)
27
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic in Rochester
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- age > 18 years.
- no prior experience with the CUFF device.
- history of elbow disarticulation, transradial, or transhumeral limb loss (non-control subjects only).
Exclusion Criteria:
- amputation for less than 6 months
- clinical history of brachial plexopathy, cervical radiculopathy or polyneuropathy
- orthopedic, joint degeneration (i.e., arthritis, verified by x-ray) affecting the hand or cervical spine that severely limit upper limb function
- visual problems that would interfere with the grasp task
- co-existing central nervous system disease with symptoms that limit upper extremity function (e.g., multiple sclerosis, motor neuron disease, myasthenia gravis, Parkinson's disease, dystonia) revealed in medical history
- significant rigidity as assessed through range of motion testing
- active psychiatric illness
- significant cognitive impairments (a score < 24 on the Mini-Mental State Examination)
- use of medications that might affect sensory and/or motor functions
- inability to effectively control myoelectrics for study purposes (control subjects only)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Patient
Testing will include assessments of activities of daily living (ADLs) by a physical therapist, biomechanical measures of forces applied to objects and motion of the upper limb collected during commonly-performed tasks, and surveys assessing user preference regarding the force feedback feature, all while using the SoftHand Pro myoelectric lower arm prosthetic and the CUFF force feedback devices in tandem, utilizing the subjects' own prosthetic sockets.
Grip force will be recorded using sensors attached to the CUFF device.
During each session, videos will be obtained of the subjects performing tasks for kinematics analysis.
The experimental sessions are organized into one to two sessions, comprising up to 16 hours, as determined by subject availability.
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Participants will complete various movement and activity of daily living (ADL) assessments to test the effectiveness of the CUFF device in combination with the Soft Hand Pro (SHP) in conveying haptic force feedback to patients with transradial limb loss, and to assess the extent to which the grip force feedback improves the embodiment of the prosthetic device.
其他名称：
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其他：Control
Testing will include assessments of activities of daily living (ADLs) by a physical therapist, biomechanical measures of forces applied to objects and motion of the upper limb collected during commonly-performed tasks, and surveys assessing user preference regarding the force feedback feature, all while using the SoftHand Pro myoelectric lower arm prosthetic and the CUFF force feedback devices in tandem, utilizing an adapter simulating a prosthetic socket.
Grip force will be recorded using sensors attached to the CUFF device.
During each session, videos will be obtained of the subjects performing tasks for kinematics analysis.
The experimental sessions are organized into one to two sessions, comprising up to 16 hours, as determined by subject availability.
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Participants will complete various movement and activity of daily living (ADL) assessments to test the effectiveness of the CUFF device in combination with the Soft Hand Pro (SHP) in conveying haptic force feedback to patients with transradial limb loss, and to assess the extent to which the grip force feedback improves the embodiment of the prosthetic device.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Conveyance of force feedback
大体时间：1 year
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Assessments will measure the extent to which the CUFF device conveys haptic force feedback, when used in combination with the Soft Hand Pro.
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1 year
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Improvement to device embodiment through addition of grip force feedback
大体时间：1 year
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Assessments will determine any improvement of device embodiment from the addition of grip force feedback to the Soft Hand Pro.
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1 year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Karen L. Andrews, M.D.、Mayo Clinic
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年10月17日
初级完成 (实际的)
2019年6月14日
研究完成 (实际的)
2019年6月14日
研究注册日期
首次提交
2018年1月21日
首先提交符合 QC 标准的
2018年1月21日
首次发布 (实际的)
2018年1月26日
研究记录更新
最后更新发布 (实际的)
2020年11月20日
上次提交的符合 QC 标准的更新
2020年11月18日
最后验证
2020年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.