A Comparison of External Mechanical Work Between Different Prosthetic Feet

Traumatic Amputation of Lower Extremity Clinical Trial

— SEW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340807
• Other study ID #: 8497.01
• Secondary ID: 01
• Status: Completed
• Phase: N/A
• First received: April 19, 2011
• Last updated: April 22, 2011
• Start date: March 2008
• Est. completion date: January 2011

Study information

• Verified date: February 2011
• Source: Miami VA Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males and/or Females between the ages of 40 and 65. b. People with unilateral transtibial amputations for vascular reasons or from traumatic events.

c. At the lowest level of function candidates will have the ability to use a prosthesis for ambulation on level surfaces at a fixed cadence.

d. People with a diagnosis of diabetes mellitus and/or peripheral vascular disease leading to amputation or people who have been amputated as a result of trauma.

e. People comfortably fitted with a prosthesis for a period of at least 6 months.

f. Candidates who score within the range of 29 to 47 on the Amputee Mobility Predictor which would indicate that subjects achieved the minimum required score to be fitted with a prosthesis.

g. Able to tolerate the testing protocol and would not fatigue at any time during testing.

h. Men's shoe size should be between 7.5 (25 cm) and 12.5 (29 cm). i. Women's shoe size should be between 8.5 (25 cm) and 13.5 (29 cm).

Exclusion Criteria:

• People who weigh more than 255 pounds at baseline visit. People receiving renal dialysis b. People with severe cardiac or pulmonary disease limiting ability to exercise including angina or poorly controlled hypertension.

c. People with neurological disorder such as or stroke that affecting ability to ambulate d. People with severe lower limb arthritis e. People with wound on non-amputated side f. People experiencing problems with prosthetic fit g. People with poor control of diabetes

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amputation, Traumatic
• Leg Injuries
• Traumatic Amputation of Lower Extremity

Intervention

Other:
• Specialized Functional Prosthetic Training
Each subject receives specialized functional prosthetic training

Locations

Country	Name	City	State
United States	Miami VAHS	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Miami VA Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symmetry in External Work	Work done by the intact and prosthetic limb	up to 12 weeks	No
Secondary	Self Report and Performance Based Assessment Instruments	PEQ-13, LCI-5, AMPPRO, 6MWT, and SAM.	up to 12 weeks	No