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A Comparison of External Mechanical Work Between Different Prosthetic Feet (SEW)

Primary Purpose

Traumatic Amputation of Lower Extremity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Specialized Functional Prosthetic Training
Sponsored by
Miami VA Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Amputation of Lower Extremity

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Miami VAHS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prosthetic Feet

Arm Description

Randomized to 4 different prosthetic feet (SACH, SAFE, TALUX, and Proprio Foot)

Outcomes

Primary Outcome Measures

Symmetry in External Work
Work done by the intact and prosthetic limb

Secondary Outcome Measures

Self Report and Performance Based Assessment Instruments
PEQ-13, LCI-5, AMPPRO, 6MWT, and SAM.

Full Information

First Posted
April 19, 2011
Last Updated
April 22, 2011
Sponsor
Miami VA Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT01340807
Brief Title
A Comparison of External Mechanical Work Between Different Prosthetic Feet
Acronym
SEW
Official Title
A Comparison of External Mechanical Work Between Bionic and Conventional Prosthetic Feet in Transtibial Amputees During Functional Activities
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Miami VA Healthcare System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Amputation of Lower Extremity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prosthetic Feet
Arm Type
Experimental
Arm Description
Randomized to 4 different prosthetic feet (SACH, SAFE, TALUX, and Proprio Foot)
Intervention Type
Other
Intervention Name(s)
Specialized Functional Prosthetic Training
Other Intervention Name(s)
Proshetic Feet
Intervention Description
Each subject receives specialized functional prosthetic training
Primary Outcome Measure Information:
Title
Symmetry in External Work
Description
Work done by the intact and prosthetic limb
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Self Report and Performance Based Assessment Instruments
Description
PEQ-13, LCI-5, AMPPRO, 6MWT, and SAM.
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Tolchin, DO
Organizational Affiliation
Miami VAHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami VAHS
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States

12. IPD Sharing Statement

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A Comparison of External Mechanical Work Between Different Prosthetic Feet

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