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Effects of Wearing a Powered Ankle-Foot Prosthesis on Amputee Walking

Primary Purpose

Traumatic Amputation of Lower Extremity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Powered ankle-foot prosthesis
No device
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Traumatic Amputation of Lower Extremity focused on measuring Unilateral below the knee amputation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 20 healthy adult volunteers, 10 unilateral trans-tibial amputees and 10 matched non-amputees, will be recruited and screened
  • Amputees must be at least 1 year post-amputation, high-functioning (at least a K3 level of ambulation), and whose cause of amputation is either traumatic or vascular. Medicare defines a K3 level amputee as an ambulator who has the ability or potential for prosthetic ambulation with variable cadence, who has the ability to traverse most environmental barriers and who may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion

Exclusion Criteria:

  • None

Sites / Locations

  • VA Medical Center, Providence

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Prosthesis

Non-amputee

Arm Description

Powered ankle-foot prosthesis and passive-elastic prosthesis

Non-amputee

Outcomes

Primary Outcome Measures

Metabolic Cost of Transport
We measured and compared gross rates of oxygen consumption and carbon dioxide production using a portable metabolic analysis system (Cosmed K4b2, IT) while participants walked at five constance velocities (0.75, 1.00, 1.25, 1.50 and 1.75 m/s) on a level treadmill (SoleFitness F85). We calculated average steady-state metabolic power in Watts (W) from 4-6 min of each trial using a standard equation. Then, we divided the metabolic power by each participant's weight and velocity to calculate the metabolic cost of transport (J/Nm).

Secondary Outcome Measures

Preferred Walking Velocity
We determined preferred walking velocity by incrementally increasing and decreasing treadmill velocity until each participant ascertained the velocity that they felt most comfortable.
Trailing Leg Step-to-step Transition Work
We calculated step-to-step transition work, the work done by each individual leg on the center of mass during transitions, using the individual limbs method described by Donelan et al. 2002. Trailing leg step-to-step transition work quantifies the amount of push-off work done by the trailing leg when both feet are on the ground during walking. Work (J) is normalized to each subject's mass (kg).

Full Information

First Posted
March 24, 2009
Last Updated
January 7, 2014
Sponsor
US Department of Veterans Affairs
Collaborators
Massachusetts Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00869947
Brief Title
Effects of Wearing a Powered Ankle-Foot Prosthesis on Amputee Walking
Official Title
Effects of Wearing a Powered Ankle-Foot Prosthesis on Amputee Walking
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
Massachusetts Institute of Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Amputees wearing a conventional prosthesis require 20-30% more metabolic energy to walk at the same speeds as non-amputees and this discrepancy is more apparent at faster walking speeds. Amputees choose to walk at speeds 30-40% slower than non-amputees. Preferred walking speed is likely influenced by elevated metabolic energy, but the underlying reason for slower preferred walking speeds is not fully understood. Unilateral amputees exhibit highly asymmetrical gait patterns that likely require more metabolic energy and impair functional mobility, increasing the risk of degenerative joint disease, osteo-arthritis and lower back pain. Improvements in prosthetic devices could enhance mobility in amputees, thus positively effecting rehabilitation and ambulation in veterans. A prosthesis that allows amputees to reduce metabolic energy would be especially useful for rehabilitation in older, ill individuals with reduced exercise capacities and could literally restore walking ability in people that are currently non-ambulatory. Hypotheses. Amputees wearing the Massachusetts Institute of Technology (MIT) Powered Ankle-Foot (PAF) prosthesis will have a lower metabolic cost, faster preferred walking speed, and improved gait symmetry during walking than amputees wearing a conventional prosthesis and will have nearly the same metabolic cost, preferred walking speed, and gait symmetry during walking as age, gender, height, and weight matched non-amputees.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Amputation of Lower Extremity
Keywords
Unilateral below the knee amputation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prosthesis
Arm Type
Experimental
Arm Description
Powered ankle-foot prosthesis and passive-elastic prosthesis
Arm Title
Non-amputee
Arm Type
Experimental
Arm Description
Non-amputee
Intervention Type
Device
Intervention Name(s)
Powered ankle-foot prosthesis
Intervention Description
The powered ankle-foot prosthesis is comprised of a series-elastic actuator (SEA) and an elastic leaf spring. This technology has been previously developed for robotic and human rehabilitation applications. The SEA allows for precise force control of the ankle joint, thus mimicking the spring-like behavior of the human ankle, as well as providing adequate energy for forward progression of the body. From the early stance period to the mid-stance period of walking, the SEA will be controlled so that the ankle joint behaves like a spring. During the late stance period, the SEA will be employed to power the forward movement of the body. The elastic leaf spring will provide shock absorption during foot strike, energy storage during early stance, and energy return during late stance.
Intervention Type
Other
Intervention Name(s)
No device
Primary Outcome Measure Information:
Title
Metabolic Cost of Transport
Description
We measured and compared gross rates of oxygen consumption and carbon dioxide production using a portable metabolic analysis system (Cosmed K4b2, IT) while participants walked at five constance velocities (0.75, 1.00, 1.25, 1.50 and 1.75 m/s) on a level treadmill (SoleFitness F85). We calculated average steady-state metabolic power in Watts (W) from 4-6 min of each trial using a standard equation. Then, we divided the metabolic power by each participant's weight and velocity to calculate the metabolic cost of transport (J/Nm).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Preferred Walking Velocity
Description
We determined preferred walking velocity by incrementally increasing and decreasing treadmill velocity until each participant ascertained the velocity that they felt most comfortable.
Time Frame
1 year
Title
Trailing Leg Step-to-step Transition Work
Description
We calculated step-to-step transition work, the work done by each individual leg on the center of mass during transitions, using the individual limbs method described by Donelan et al. 2002. Trailing leg step-to-step transition work quantifies the amount of push-off work done by the trailing leg when both feet are on the ground during walking. Work (J) is normalized to each subject's mass (kg).
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 20 healthy adult volunteers, 10 unilateral trans-tibial amputees and 10 matched non-amputees, will be recruited and screened Amputees must be at least 1 year post-amputation, high-functioning (at least a K3 level of ambulation), and whose cause of amputation is either traumatic or vascular. Medicare defines a K3 level amputee as an ambulator who has the ability or potential for prosthetic ambulation with variable cadence, who has the ability to traverse most environmental barriers and who may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alena Grabowski, PhD BA
Organizational Affiliation
VA Eastern Colorado Health Care System, Denver, CO
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Providence
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States

12. IPD Sharing Statement

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Effects of Wearing a Powered Ankle-Foot Prosthesis on Amputee Walking

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