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OpenTrials
Completed

NCT Number: NCT01622530

Development of a Simulation Tool for Upper Extremity Prostheses

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).

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Key information

Conditions

Traumatic Amputation of Upper Limb, Level Unspecified

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of South Floria RRT building

Tampa, Florida, 33612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Jun 19, 2012
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.