NCT01340807

A Comparison of External Mechanical Work Between Different Prosthetic Feet

A Comparison of External Mechanical Work Between Bionic and Conventional Prosthetic Feet in Transtibial Amputees During Functional Activities

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Miami VA Healthcare System · Federal
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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?

Detailed description

The study examined the application of outcome measures to determine changes in function of unilateral transtibial amputees (TTAs) caused by specialized functional prosthetic training (training) and the use of four different prosthetic feet. Two self-report measures i.e. the Prosthetic Evaluation Questionnaire (PEQ-13) and Locomotor Capability Index (LCI-5), and three performance-based measures i.e. the Amputee Mobility Predictor (AMPPRO), Six-minute Walk Test (6MWT), and Step Activity Monitor (SAM) were utilized. Healthy unilateral Transtibial Amputees between the age of 40-65 will participate in the study. Subjects were tested at baseline, after receiving training with their existing prosthesis, and with the study socket and four prosthetic feet i.e. SACH, SAFE, Talux and PROPRIO FOOT over an 8-10 week period. Training was administered between testing sessions.

Conditions

• Traumatic Amputation of Lower Extremity

Interventions

Type	Name	Description
OTHER	Specialized Functional Prosthetic Training	Each subject receives specialized functional prosthetic training

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-01-01
• Completion: 2011-01-01
• First posted: 2011-04-25
• Last updated: 2011-04-25

Locations

1 site across 1 country: United States