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

US Department of Veterans Affairs (VA) logo

US Department of Veterans Affairs (VA)

Status

Completed

Conditions

Traumatic Amputation of Lower Extremity

Treatments

Other: No device
Device: Powered ankle-foot prosthesis

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT00869947
A6749-M

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

16 participants in 2 patient groups

Prosthesis
Experimental group
Description:
Powered ankle-foot prosthesis and passive-elastic prosthesis
Treatment:
Device: Powered ankle-foot prosthesis
Non-amputee
Experimental group
Description:
Non-amputee
Treatment:
Other: No device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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