Development of a Simulation Tool for Upper Extremity Prostheses
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|ClinicalTrials.gov Identifier: NCT01622530|
Recruitment Status : Recruiting
First Posted : June 19, 2012
Last Update Posted : March 29, 2017
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 or disease|
|Traumatic Amputation of Upper Limb, Level Unspecified|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Development of a Simulation Tool for Upper Extremity Prostheses|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
upper limb amputees
No longer recruiting non-amputees
- Shoulder angle [ Time Frame: 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.
- Elbow angle [ Time Frame: 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.
- Wrist angle [ Time Frame: During task completion ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622530
|Contact: Stephanie L Carey, PhDemail@example.com|
|Contact: Dimitri Menychtas, PhDfirstname.lastname@example.org|
|United States, Florida|
|University of South Floria RRT building||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Stephanie Carey, PhD 813-974-5765 email@example.com|
|Contact: Derek Lura, MS, PhD (c) 813-974-9651 firstname.lastname@example.org|
|Principal Investigator:||Rajiv Dubey, PhD||University of South Florida|