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Clinical Trials/NCT00869947
NCT00869947
Completed
N/A

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

US Department of Veterans Affairs1 site in 1 country16 target enrollmentMarch 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Traumatic Amputation of Lower Extremity
Sponsor
US Department of Veterans Affairs
Enrollment
16
Locations
1
Primary Endpoint
Metabolic Cost of Transport
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
January 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

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

  • Not provided

Outcomes

Primary Outcomes

Metabolic Cost of Transport

Time Frame: 1 year

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 Outcomes

  • Trailing Leg Step-to-step Transition Work(1 year)
  • Preferred Walking Velocity(1 year)

Study Sites (1)

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