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A Comparison of External Mechanical Work Between Different Prosthetic Feet

NCT01340807 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2011-04-25

No results posted yet for this study

Summary

Recent dysvascular and diabetic amputees as well as older, long-term traumatic amputees are at risk of functional decline, joint degeneration, skin breakdown and further limb loss due to the forces placed on the contralateral limb through prosthetic ambulation. If specialized prosthetic gait training and proper use of the appropriate prosthetic foot can decrease forces on the intact limb, the long term health and quality of life of veterans with amputations could be substantially improved. We will address two key questions:

Key Question 1: After receiving specialized gait training and a new prosthetic socket, will subjects demonstrate differences in gait symmetry and external mechanical work between the bionic and conventional prosthetic feet, while performing various functional activities.

Key Question 2: Can external mechanical work be used as a clinically friendly measure to differentiate between prosthetic feet?

Conditions

  • Traumatic Amputation of Lower Extremity

Interventions

OTHER

Specialized Functional Prosthetic Training

Each subject receives specialized functional prosthetic training

Sponsors & Collaborators

  • Miami VA Healthcare System

    lead FED

Principal Investigators

  • Ronald Tolchin, DO · Miami VAHS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01340807 on ClinicalTrials.gov