N/A
N=16
Effects of Wearing a Powered Ankle-Foot Prosthesis on Amputee Walking
Traumatic Amputation of Lower Extremity
Bottom Line
View on ClinicalTrials.gov: NCT00869947 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Metabolic Cost of Transport — 4.76; 4.57; 4.68; 4.11 J/Nm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Powered ankle-foot prosthesis (Device); No device (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Metabolic Cost of Transport |
4.76; 4.57; 4.68; 4.11; 3.77; 3.71 | — |
| SECONDARY Preferred Walking Velocity |
1.16; 1.42; 1.41 | — |
| SECONDARY Trailing Leg Step-to-step Transition Work |
0.114; 0.155; 0.165; 0.125; 0.194; 0.179 | — |
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
Data sourced from ClinicalTrials.gov (NCT00869947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.