CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Transverse plane rotation adaptor pylon +1 moredevice
Likely dose
Not stated in record
Key inclusion· 8
  • Unilateral trans-tibial amputee
  • Age 18–70 years
  • Weight ≤220 pounds
  • Prosthesis use for ≥2 years
Key exclusion· 2
  • Amputation due to tumor or active/treated tumor
  • Leg pain or conditions interfering with walking

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

Search/NCT00167778
NCT00167778N/ACompleted

Turning Corners: Prosthetic Components and Stability in Amputee Gait

US Department of Veterans Affairs·interventional·Posted Sep 14, 2005·Updated Aug 15, 2014

In Brief

A clinical study evaluating Transverse plane rotation adaptor pylon and Rigid pylon for Diabetes Mellitus and 2 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The biomechanics of changing direction while walking has been largely neglected despite its relevancy to functional mobility. In addition, an increased risk of injury can be associated with turning due to a decrease in stability. The objective of this study is to understand the biomechanics of turning gait in sample populations of intact and trans-tibial amputees and the capacity of prosthetic components to facilitate transverse plane movement. The clinical impact of this investigation is the development of interventions that increase functional mobility, stability and safety while turning. The researchers propose to investigate three sets of hypotheses. The first set addresses the fundamental biomechanical mechanisms associated with walking along a circular trajectory, how intact subjects differ from amputees, and the effect of a rotation adaptor pylon. The second set of hypotheses addresses dynamic stability and the potential influence of prosthetic interventions. The third set of hypotheses addresses how the rotational properties of the prosthetic pylon can influence comfort and mobility during daily activities.

Study Details

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

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2005
Enrollment StartJan 1, 2005
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 20.8 years ago

Interventions

Transverse plane rotation adaptor pylondevice

Potential future practice

Rigid pylondevice

Current clinical practice