Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver
About this trial
A clinical trial utilizing cross-over study design in which individuals with transtibial amputation using either a bone-anchored limb or standard socket prosthesis will perform activities of daily living with varying prosthetic foot stiffness categories to complete the following 4 Specific Aims: 1) Determine the influence of prosthetic foot stiffness on dynamic bone-implant loading, 2) Determine how prosthetic foot stiffness influences function, pain, and multi-joint biomechanics outcomes, 3) Establish how prosthetic foot stiffness influences osseoperception and fall risk, and 4) Establish target ranges of optimal foot stiffness based on the sensitivity biomechanical outcomes to variability in foot stiffness.
Eligibility criteria
Qualifiers
Unilateral transtibial amputation due to traumatic, congenital, or cancer-related causes
> 12-months bone-anchored limb implantation surgery (Bone Anchored Limb group)
> 12-months limb amputation (Socket Control group)
Non-vascular amputation etiology
Disqualifiers
Major amputation on contralateral limb
Vascular amputation etiology
Neurologic pathology that impairs coordination/balance
Regular assistive device use required for community ambulation
Trial design
Treatments tested in this trial
- As-prescribed prosthetic foot stiffness
- A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot
- A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Colorado, Denver
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov