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Clinical Trials/NCT00417352
NCT00417352CompletedNot Applicable

Kinematic and Kinetic Profile of Common Tasks for the Development of Design Parameters of an Upper Limb Prosthesis

University of South Florida2 sites in 1 country17 target enrollmentStarted: December 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
17
Locations
2
Primary Endpoint
shoulder abduction

Study Overview

Brief Summary

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.

Detailed Description

PROBLEM STATEMENT:

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.

SYNOPSIS OF CURRENT LITERATURE:

Restricted motion and excess weight of an upper limb prosthesis have been documented as complaints among amputees [1], [2], [3], [4], [5], [6]. Through surveys Atkins et al. determined that amputees would like the wrist component of the prosthesis to perform more movements. This study also listed drinking from a glass and opening a door, top priorities among amputees [7]. This suggests that the wrist component on a prosthetic arm is important.

There are many examples throughout scientific literature showing how kinetic, kinematic and metabolic analyses of gait have lead to the improvement of lower limb prosthetic design criteria [8],[9]. In 2003, Twiste et al. conducted a literature review on rotation and translation of the anatomic joints during prosthetic gait. The abstract from this review mentions that more accurate kinematic gait analysis showing optimized gait patterns could help manufacturers design prosthetic components to mimic these patterns [9]. The effects of mass perturbations on lower limb amputees have been investigated to determine how inertial properties of a prosthesis should be evaluated [10].

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

shoulder abduction

shoulder flexion

elbow flexion

shoulder joint force

should joint torque

elbow joint force

elbow joint torque

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (2)

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