Quantifying Prosthetic Socket Interface Movement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01932892
First received: May 8, 2013
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

This study will quantify motion occurring at the socket interface of transhumeral prosthesis users during common tasks. Participants in the study will use a body powered prosthesis with a hosmer hook terminal device. A motion analysis system and a novel optical sensor embedded into the socket wall will record the amount of movement between the residual limb and socket of the prosthesis. Participants will complete range of motion and functional tasks. The range of motion tasks include shoulder flexion, abduction and rotation as well as elbow flexion. The functional tasks include bilateral lift of weighted basket, unilateral lift of weighted handle, box and blocks test, walk and carry a gallon of milk, and folding a towel. It is expected that the more weight at the terminal device the more rotation at the interface, as well as more slip between residual limb and device. It is also expected that the soft tissues of the residual limb can be modeled as a nonlinear spring and the amount of movement at the interface can be predicted based off the force in the system.


Condition
Transhumeral Amputation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Quantifying Prosthetic Socket Interface Movement

Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Magnitude of prosthetic socket rotation and slip [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Motion capture data and optical sensor data will be used to calculate the amount of prosthetic socket rotation and slip. It is predicted that current socket designs will have some degree of socket movement during normal activities due to soft tissue deformation.


Secondary Outcome Measures:
  • Magnitude of prosthetic socket movement relative to end effector loading [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Motion capture data and optical sensor data will be used to calculate the amount of socket movement compared to the terminal device loading for the various tasks. It is predicted that tasks which have more load at the terminal device will result in more socket movement.

  • Magnitude of prosthetic socket movement relative to the amount of residual limb rotation. [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    The amount of socket movement will be compared to the amount of residual limb rotation for each task. Residual limb rotation is the angle between the upper arm segment and the scapula segment. It is hypothesized the greater the residual limb angle, the greater the amount of socket movement.

  • Difference in range of motion of the shoulder joint between no prosthesis, the original prosthetic socket, and the duplicate socket [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    It is predicted that the range of motion of the shoulder will be statistically the same between the original and duplicate socket.


Enrollment: 10
Study Start Date: May 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Transhumeral prosthesis user
Transhumeral body-powered prosthesis user

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

Inclusion Criteria:

  • Transhumeral amputee
  • Uses prosthesis
  • Used same socket without documented skin condition for at least 2 months

Exclusion Criteria:

  • Current skin condition on part of residual limb
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01932892

Locations
United States, Florida
Rehabilitation Robotics and Prosthetics Testbed
Tampa, Florida, United States, 33617
Sponsors and Collaborators
University of South Florida
Investigators
Study Director: Stephanie Carey, PhD University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01932892     History of Changes
Other Study ID Numbers: 20130075
Study First Received: May 8, 2013
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
transhumeral

ClinicalTrials.gov processed this record on July 24, 2014