Assessing the Effectiveness of Upper-limb Force Feedback With the SoftHand Pro Myoelectric Prosthesis in Persons With Transradial Limb Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Conveyance of force feedback
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 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
- •age > 18 years.
- •no prior experience with the CUFF device.
- •history of elbow disarticulation, transradial, or transhumeral limb loss (non-control subjects only).
排除标准
- •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)
结局指标
主要结局
Conveyance of force feedback
时间窗: 1 year
Assessments will measure the extent to which the CUFF device conveys haptic force feedback, when used in combination with the Soft Hand Pro.
Improvement to device embodiment through addition of grip force feedback
时间窗: 1 year
Assessments will determine any improvement of device embodiment from the addition of grip force feedback to the Soft Hand Pro.
次要结局
未报告次要终点
研究者
Kristin Zhao, PhD
Principal Investigator
Mayo Clinic