CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
Powered ankle-foot prosthesis +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00869947
NCT00869947N/ACompleted

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

US Department of Veterans Affairs·interventional·Posted Mar 26, 2009·Updated Feb 25, 2014

In Brief

A clinical study evaluating Powered ankle-foot prosthesis and No device for Traumatic Amputation of Lower Extremity. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 26, 2009
Enrollment StartMar 1, 2009
Primary CompletionJun 1, 2011
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.3 years ago

Interventions

Powered ankle-foot prosthesisdevice

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.

No deviceother