Study of Compensatory Motion While Using an Upper Limb Prosthesis

This study has been completed.
Sponsor:
Information provided by:
University of South Florida
ClinicalTrials.gov Identifier:
NCT00417352
First received: December 28, 2006
Last updated: August 5, 2010
Last verified: December 2006
  Purpose

Current improvements of the design of the upper limb prosthesis include advanced technology in control systems and electronic circuitry that mimic human motion and improve function of the prosthesis. Often times these improvements require large amounts of power, circuitry and excess mass distally along the prosthesis that may require greater effort from the user. Poor function of an upper limb prosthesis may cause awkward compensatory motion. Aberrant movements, such as these compensatory movements are known to cause greater stress to remaining joints. Amputees are forced to decide if the extra function provided by the advanced electronics is worth carrying the extra mass which may cause fatigue, socket issues and greater stress on the remaining joints. An example is the wrist rotator component of an upper limb prosthesis which may allow greater function and reduce compensatory motion, but adds mass distally, potentially causing greater torques on remaining joints.

GOALS OF THE STUDY:

There are two main goals of this study:

  1. to determine the impact of an upper limb prosthesis without a wrist rotator on the compensatory motion and torques in the remaining joints during common tasks
  2. to determine the impact of the location (distally or proximally) of a wrist rotator on a upper limb prosthesis on the compensatory motion during common tasks

HYPOTHESES:

  1. There will be a statistically significant difference in range of motion of the upper limb joints between healthy subjects, braced subjects and upper limb amputees during four common tasks.
  2. There will be a statistically significant difference in joint upper limb joint torques between healthy subjects, braced subjects and upper limb amputees during three common tasks.
  3. There will be a statistically significant difference in upper limb angles and joint torques between mass added distally and mass added proximally during common tasks.

Condition Intervention
Prosthesis
Device: Brace
Device: Added mass

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Kinematic and Kinetic Profile of Common Tasks for the Development of Design Parameters of an Upper Limb Prosthesis

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • shoulder abduction
  • shoulder flexion
  • elbow flexion
  • shoulder joint force
  • should joint torque
  • elbow joint force
  • elbow joint torque

Enrollment: 17
Study Start Date: December 2006
Study Completion Date: May 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ages 18-60 years old
  • Control group: normal, healthy volunteers
  • Amputee group: unilateral, transradial myoelectric prosthesis users

Exclusion Criteria:

  • elderly > 60
  • children < 18
  • pregnant women
  • persons with shoulder impairments, injuries, or problems
  • bilateral upper limb amputees
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00417352

Locations
United States, Florida
University of South Florida
Tampa, Florida, United States, 33620
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Stephanie L Carey, PhD University of South Florida
  More Information

No publications provided

Responsible Party: Stephanie L. Carey, University of South Florida Mechanical Engineering Dept.
ClinicalTrials.gov Identifier: NCT00417352     History of Changes
Other Study ID Numbers: Compensatory motion
Study First Received: December 28, 2006
Last Updated: August 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
no intervention
bracing restricted forearm and wrist movement
bracing with added mass near elbow
bracing with added mass near wrist

ClinicalTrials.gov processed this record on September 18, 2014