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Effects of Wearing a Powered Ankle-Foot Prosthesis on Amputee Walking
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, March 2009
First Received: March 24, 2009   No Changes Posted
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00869947
  Purpose

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 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.


Condition Intervention
Amputation
Device: Powered ankle-foot prosthesis

MedlinePlus related topics: Amputees Foot Health Methamphetamine Rehabilitation
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Open Label, Factorial Assignment, Efficacy Study
Official Title: Effects of Wearing a Powered Ankle-Foot Prosthesis on Amputee Walking

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Metabolic cost of transport [ Time Frame: After clinical trials are completed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Preferred walking speed [ Time Frame: After clinical trials are completed ] [ Designated as safety issue: No ]
  • Gait symmetry [ Time Frame: After clinical trials are completed ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Powered ankle-foot prosthesis
Device: Powered ankle-foot prosthesis
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869947

Contacts
Contact: Alena Grabowski, PhD (720) 435-4270 alenag@media.mit.edu

Locations
United States, Rhode Island
VA Medical Center, Providence Recruiting
Providence, Rhode Island, United States, 02908
Contact: Alena Grabowski, PhD     720-435-4270     alenag@media.mit.edu    
Principal Investigator: Alena Grabowski, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Alena Grabowski, PhD VA Medical Center, Providence
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs ( Grabowski, Alena - Principal Investigator )
Study ID Numbers: A6749M
Study First Received: March 24, 2009
Last Updated: March 24, 2009
ClinicalTrials.gov Identifier: NCT00869947     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Unilateral below the knee amputation

ClinicalTrials.gov processed this record on May 07, 2009