Development of a Simulation Tool for Upper Extremity Prostheses

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of South Florida
Sponsor:
Information provided by (Responsible Party):
Stephanie L. Carey, University of South Florida
ClinicalTrials.gov Identifier:
NCT01622530
First received: June 7, 2012
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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).


Condition
Traumatic Amputation of Upper Limb, Level Unspecified

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Development of a Simulation Tool for Upper Extremity Prostheses

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Shoulder angle [ Time Frame: During task completion ] [ Designated as safety issue: No ]
    The shoulder angle (rotation, flexion/extension and abduction/adduction) will be measured during several tasks during one 3-4 hour testing period.

  • Elbow angle [ Time Frame: During task completion ] [ Designated as safety issue: No ]
    The elbow angle ( flexion/extension and forearm pronation/supination) will be measured during several tasks during one 3-4 hour testing period.

  • Wrist angle [ Time Frame: During task completion ] [ Designated as safety issue: No ]
    The wrist angle (flexion/extension and abduction/adduction) will be measured during several tasks during one 3-4 hour testing period.

  • Torso angle [ Time Frame: During task completion ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Validation of robotics based human body model [ Time Frame: After motion data analysis ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: July 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Amputees
upper limb amputees
Control
non-amputees, healthy volunteers

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622530

Contacts
Contact: Stephanie L Carey, PhD 813-974-5765 scarey3@usf.edu
Contact: Derek Lura, PhD 813-974-9651 dlura@mail.usf.edu

Locations
United States, Florida
University of South Floria RRT building Recruiting
Tampa, Florida, United States, 33612
Contact: Stephanie Carey, PhD    813-974-5765    scarey3@usf.edu   
Contact: Derek Lura, MS, PhD (c)    813-974-9651    dlura@mail.usf.edu   
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Rajiv Dubey, PhD University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: Stephanie L. Carey, Assistant Research Professor, University of South Florida
ClinicalTrials.gov Identifier: NCT01622530     History of Changes
Other Study ID Numbers: Pro00000991, 09128006
Study First Received: June 7, 2012
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Amputation, Traumatic
Wounds and Injuries

ClinicalTrials.gov processed this record on July 29, 2014