Clinical trial NCT01622530: Development of a Simulation Tool for Upper Extremity Prostheses
Official title: Development of a Simulation Tool for Upper Extremity Prostheses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Amputation of Upper Limb, Level Unspecified
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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).

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 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.

Primary outcomes:
measure: Shoulder angle
timeFrame: During task completion
measure: Elbow angle
timeFrame: During task completion
measure: Wrist angle
timeFrame: During task completion
measure: Torso angle
timeFrame: During task completion
Secondary outcomes:
measure: Validation of robotics based human body model
timeFrame: After motion data analysis
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Floria RRT building
state: Florida
Study officials:
affiliation: University of South Florida
name: Rajiv Dubey, PhD
role: PRINCIPAL_INVESTIGATOR
References: