跳至主要内容
临床试验/NCT01622530
NCT01622530已完成不适用

Development of a Simulation Tool for Upper Extremity Prostheses

University of South Florida1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Elbow angle

研究概览

简要总结

Amputees often choose not to wear prostheses due to marginal performance or may settle for a prosthesis that offers only cosmetic improvement, but lacks function. A simulation tool consisting of a robotics-based human body model (RHBM) to predict functional motions, and integrated modules for aid in prescription, training, comparative study, and determination of design parameters of upper extremity prostheses will be developed.

The main objective of collecting and analyzing human movement during several common tasks is to optimize and validate the robotics based human model. The range of motion data of subjects performing activities of daily living such as opening a door, turning a wheel, grooming, eating, bilateral lifting, as well as recreational and sport activities such as swinging a baseball bat, and golf club will be analyzed. This motion analysis data will also be used to compare data between four groups: a control group (n=10), a braced group simulating prosthesis use (n=10), a group wearing a transradial prosthesis (n=10) and a group wearing a transhumeral prosthesis (n =10).

详细描述

Data will be collected by an 8 camera Vicon© motion analysis system during one 3-4 hour testing period. Forty-five reflective markers will be attached to subjects skin and clothing via a double sided adhesive electrode collar. The cameras work on an infrared spectrum and the markers are passive reflective spheres. Relations between marker positions and anatomical / known positions on the body are used to calculate the positions of body segments.This analysis will provide information on movement strategies, compensatory motion, and socket movement associated with the selected tasks for transradial and transhumeral prostheses. Differences in the range of motion of the prostheses users and control subjects will be calculated to determine compensatory motion. The movement of the prosthesis's socket as a function of task and other factors will also be measured. Measured data will be used to minimize error in the simulation of the upper body movement. Knowledge of human motor function given in the recorded data can be extended to give insight to movement parameters when designing new prosthetics. Simulations will be optimized to the collected data using a regressive best fit method.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • All subjects will be capable of providing an informed consent.
  • Normal healthy adult subjects and upper limb amputees that currently use a prosthesis to complete activities of daily living will be included.

排除标准

  • Subjects younger than 18 or older than 65 will be excluded.
  • Adults that are unable to consent will be excluded from the study.
  • Subjects that have health issues or injuries that would prevent them from lifting five pounds or completing simple tasks of daily living will be excluded from the study.
  • Subjects will be asked if they are able to lift five pounds, open a door and drink from a cup without pain or injury. Before study set up and recording begins, subjects will be asked to practice these tasks to insure that they are capable of completing them.
  • Pregnant women will be excluded from this study due to the changes in some physical abilities during pregnancy.

结局指标

主要结局

Elbow angle

时间窗: During task completion

The elbow angle ( flexion/extension and forearm pronation/supination) will be measured during several tasks during one 3-4 hour testing period.

Torso angle

时间窗: During task completion

The torso angle (rotation, forward/backward bending and right/left sideways bending) will be measured during several tasks during one 3-4 hour testing period.

Shoulder angle

时间窗: During task completion

The shoulder angle (rotation, flexion/extension and abduction/adduction) will be measured during several tasks during one 3-4 hour testing period.

Wrist angle

时间窗: During task completion

The wrist angle (flexion/extension and abduction/adduction) will be measured during several tasks during one 3-4 hour testing period.

次要结局

  • Validation of robotics based human body model(After motion data analysis)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephanie L. Carey

Assistant Research Professor

University of South Florida

研究点 (1)

Loading locations...

相似试验