Development of a Simulation Tool for Upper Extremity Prostheses

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).

Study Overview

• Status: Completed
• Conditions: Traumatic Amputation of Upper Limb, Level Unspecified

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • University of South Floria RRT building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Two groups will be studied: non-amputees and upper limb amputees. The subjects will be recruited from around the community.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Amputees; upper limb amputees
Non-amputees; No longer recruiting non-amputees

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder angle	The shoulder angle (rotation, flexion/extension and abduction/adduction) will be measured during several tasks during one 3-4 hour testing period.	During task completion
Elbow angle	The elbow angle ( flexion/extension and forearm pronation/supination) will be measured during several tasks during one 3-4 hour testing period.	During task completion
Wrist angle	The wrist angle (flexion/extension and abduction/adduction) will be measured during several tasks during one 3-4 hour testing period.	During task completion
Torso angle	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.	During task completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of robotics based human body model	The robotics based human body model will be validated by comparing the joints (shoulder, elbow, wrist, torso) angles collected from the motion analysis system while participants are completing activities of daily living with the joint angles predicted by the model. The two data sets will be compared using a root mean error calculation.	After motion data analysis

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Rajiv Dubey, PhD, University of South Florida

Publications and helpful links

Helpful Links

• Center for Rehabilitation, Robotics and Assistive Technologies

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2010
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: June 7, 2012
• First Submitted That Met QC Criteria: June 14, 2012
• First Posted (Estimate): June 19, 2012

Study Record Updates

• Last Update Posted (Actual): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 14, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: Pro00000991; 09128006 (Other Grant/Funding Number: U.S. Department of Defense (TATRC))