Traumatic Amputation of Upper Limb, Level Unspecified Clinical Trial
Official title:
Development of a Simulation Tool for Upper Extremity Prostheses
| Verified date | September 2018 |
| Source | University of South Florida |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | December 2017 |
| Est. primary completion date | August 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of South Floria RRT building | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of South Florida |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | 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 |