Toward Use of the Synergy-based SoftHand Pro for Activities of Daily Living by Persons With Transradial Limb Loss: A Multi-site Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Upper Extremity Functional Ability [1]
研究概览
简要总结
A trial to compare the performance of the SoftHand Pro (SHP) and Ossur i-Limb in people with transradial limb loss over an 8-week period.
详细描述
This study will measure improvements in outcomes obtained from laboratory testing of the SHP and i-Limb from baseline to after 8 weeks of daily use. A secondary analysis will incorporate the subjects' existing prosthetic hands. Finally, surveys and usage data collected through the SHP and i-Limb firmware during daily use will complement data the aforementioned outcomes to explore factors that may be related to differences in grasping and manipulation performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the individual can successfully use their prosthesis, list the components used and that their current prosthesis is fitting properly (by performing a tension analysis);
- •the individual had unilateral transradial limb loss more than 6 months before the clinical evaluation because, to use a myoelectric prosthesis, the residual limb volume needs to be stable;
- •the individual is a proficient owner of one or more common myoelectric prosthetic hands, such as the Sensor Hand Speed and Bebionic.
排除标准
- •individuals who have had transradial amputation for less than 6 months;
- •individuals who have been fit and trained to use a prosthesis but chose not to use one;
- •individuals who use the i-Limb Quantum myoelectric prosthesis;
- •symptomatic brachial plexopathy, cervical radiculopathy or polyneuropathy (observed);
- •orthopedic, joint degeneration (i.e., arthritis, self-reported) affecting the hand or cervical spine that severely limit upper limb function (observed);
- •visual problems that would interfere with the grasping;
- •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;
- •limited range of motion as assessed through range of motion testing;
- •inability to follow study instructions;
- •use of medications that might affect sensory and/or motor functions.
研究组 & 干预措施
Initial Assignment: SoftHand Pro
This arm of the crossover design will begin the trial using the SoftHand Pro.
干预措施: Ossur i-Limb (Device)
Initial Assignment: Ossur i-Limb
This arm of the crossover design will begin the trial using the i-Limb.
干预措施: SoftHand Pro (Device)
Initial Assignment: Ossur i-Limb
This arm of the crossover design will begin the trial using the i-Limb.
干预措施: Ossur i-Limb (Device)
Initial Assignment: SoftHand Pro
This arm of the crossover design will begin the trial using the SoftHand Pro.
干预措施: SoftHand Pro (Device)
结局指标
主要结局
Upper Extremity Functional Ability [1]
时间窗: 8 Weeks
Change in upper extremity function, as measured by the Activities Measure for Upper Limb Amputees (AM-ULA). Participants complete 17 tasks, rated on task completion, speed of completion, movement quality, skillfulness of prosthesis use, and independence from the use of other assistive devices or adaptive environments with the prosthesis. The scale is 0 to 4, with a higher number representing higher performance in each category. Scores in each category are averaged for a Grade in each task. Grades for the 17 tasks are averaged and multiplied by 40 for a final score of 0 - 40, with a higher number representing higher overall function.
次要结局
- Upper Extremity Manual Dexterity(8 Weeks)
- Overall Functional Performance(8 Weeks)
- Arm Pain(8 Weeks)
- Upper Extremity Functional Ability [2](8 Weeks)
- Hand Motor Function(8 Weeks)
- Prosthesis Overall Functional Utility(8 Weeks)
- Occupational Performance(8 Weeks)
- Quality of Life(8 Weeks)
- Upper Extremity Function and Pain(8 Weeks)
研究者
Kristin Zhao, PhD
Principal Investigator
Mayo Clinic