Clinical trial NCT00869947: 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
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Amputation of Lower Extremity
Keywords: Unilateral below the knee amputation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Massachusetts Institute of Technology
First posted: 2009-03-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Metabolic Cost of Transport
timeFrame: 1 year
Secondary outcomes:
measure: Preferred Walking Velocity
timeFrame: 1 year
measure: Trailing Leg Step-to-step Transition Work
timeFrame: 1 year
Other outcomes:
Locations:
city: Providence
country: United States
facility: VA Medical Center, Providence
state: Rhode Island
Study officials:
affiliation: VA Eastern Colorado Health Care System, Denver, CO
name: Alena Grabowski, PhD BA
role: PRINCIPAL_INVESTIGATOR
References: