Quantifying Prosthetic Socket Interface Movement
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
- Magnitude of prosthetic socket rotation and slip
研究概览
简要总结
This study will quantify motion occurring at the socket interface of transhumeral prosthesis users during common tasks. Participants in the study will use a body powered prosthesis with a hosmer hook terminal device. A motion analysis system and a novel optical sensor embedded into the socket wall will record the amount of movement between the residual limb and socket of the prosthesis. Participants will complete range of motion and functional tasks. The range of motion tasks include shoulder flexion, abduction and rotation as well as elbow flexion. The functional tasks include bilateral lift of weighted basket, unilateral lift of weighted handle, box and blocks test, walk and carry a gallon of milk, and folding a towel. It is expected that the more weight at the terminal device the more rotation at the interface, as well as more slip between residual limb and device. It is also expected that the soft tissues of the residual limb can be modeled as a nonlinear spring and the amount of movement at the interface can be predicted based off the force in the system.
详细描述
Participation in the study will begin at the socket duplication stage/initial testing phase and end no more than a week later after the second collection day is complete. Subjects will meet individually with the PI at lab on testing day one to have their socket duplicated and do some initial testing. Socket duplication will consist of filling the inside volume of the socket with a plaster mixture to form a positive mold. Once set, this positive mold can be removed and used by a contractor to form the clear thermoplastic socket over it. After the mold has been made, the subject will perform a series of tasks while being recorded by an 8 camera Vicon motion analysis system and 2 digital video cameras. Thirty reflective markers will be placed on the subject using an adhesive collar. There is slight risk of skin irritation due to the adhesive tape, similar to wearing a Band-Aid. Some discomfort may arise while removing the markers. A tight fitting shirt will be worn by participants to limit undesired motion of the markers due to loose clothing. Subjects will complete:
- Range of Motion Trials (without prosthesis)
o The Range of Motion (ROM) trials include shoulder flexion/extension, shoulder abduction/adduction, and shoulder rotation. Each RoM task will be repeated three times.
- Trinity Amputation and Prosthesis Experience Scales (TAPES)
- This questionnaire looks at different aspects of having and using a prosthesis.
- Results of this questionnaire will be compared to performance in the laboratory setting to see the correlation between how the user rates the device and how the perform with it.
The first collection day will last about 1-2 hours. For the second collection day, subjects will be randomized into group A or B to determine the order of sockets tested during data collection on the second day. Subjects in group A will use their original prosthesis in the first collection while group B subjects will use their duplicate socket prosthesis. Subjects will switch to the other socket for the second collection session. The second day is expected to last about 3-4 hours. Each session will consist of the following:
- Range of Motion Trials (with prosthesis)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Transhumeral amputee
- •Uses prosthesis
- •Used same socket without documented skin condition for at least 2 months
排除标准
- •Current skin condition on part of residual limb
结局指标
主要结局
Magnitude of prosthetic socket rotation and slip
时间窗: 3 hours
Motion capture data and optical sensor data will be used to calculate the amount of prosthetic socket rotation and slip. It is predicted that current socket designs will have some degree of socket movement during normal activities due to soft tissue deformation.
次要结局
- Magnitude of prosthetic socket movement relative to the amount of residual limb rotation.(3 hours)
- Magnitude of prosthetic socket movement relative to end effector loading(3 hours)
- Difference in range of motion of the shoulder joint between no prosthesis, the original prosthetic socket, and the duplicate socket(3 hours)