Development of a Simulation Tool for Upper Extremity Prostheses
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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 |
- 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.
- 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 2013 |
| Estimated Primary Completion Date: | December 2013 (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 |
Two groups will be studied: non-amputees and upper limb amputees. The subjects will be recruited from around the community.
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| Contact: Stephanie L Carey, PhD | 813-974-5765 | scarey3@usf.edu |
| Contact: Derek Lura, PhD | 813-974-9651 | dlura@mail.usf.edu |
| 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 | |
| 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: | February 4, 2013 |
| 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 June 17, 2013