NCT03651830

A Test-Drive Strategy for the Prescription of Prosthetic Feet for People With Leg Amputations

Completed NA Last updated 20 February 2024

What this trial tests

NA trial testing Prosthetic Foot Emulator in Amputation in 90 participants. Completed in 14 June 2022.

Timeline

24 September 2018

Primary endpoint
20 May 2021

14 June 2022

Quick facts

Lead sponsor	Seattle Institute for Biomedical and Clinical Research
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	90
Start date	24 September 2018
Primary completion	20 May 2021
Estimated completion	14 June 2022
Sites	3 locations across United States

Drugs / interventions tested

• Prosthetic Foot Emulator
• Commercially available prosthetic feet

Conditions studied

• Amputation — all drugs for Amputation →

Sponsor

Seattle Institute for Biomedical and Clinical Research

Who can join

Adults 18 to 89, any sex, with Amputation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objective/Hypotheses and Specific Aims: The primary aim of this proposal is to determine whether a PFE can be used to predict foot preference and mobility outcomes with corresponding commercial prosthetic feet in people with a unilateral transtibial amputation (TTA). Secondarily, the investigators aim to determine whether a brief trial of commercial prosthetic feet would be able to similarly predict longer-term foot preference and mobility outcomes with those feet.

Study Design: The investigators will use a participant blinded cross-over study with repeated measurements. Participants with TTA will be enrolled at each of the three study sites: two VA sites (Puget Sound and Minneapolis), and one Department of Defense site (Center for the Intrepid). Participants will complete up to 6 visits. After an initial assessment visit, participants will be assigned to the high or low mobility group, and then during visit 2 they will be randomized to use the PFE in three foot modes or the three corresponding actual (commercially available) feet during walking tests in the laboratory. During visit 3 participants will repeat the procedures in the other condition (e.g., PFE if Day 2 included actual feet testing). At the end of visit 3 participants will be fit with one of the actual feet and wear it at home and in the community for approximately two weeks. At visit 4 participants will be fit with the next actual foot and repeat the 2 week use window. The same process will be followed for the final foot at visit 5, and the study foot will be returned at visit 6. Participants' preference, satisfaction and perceived mobility, and functional mobility will be measured and compared across all foot conditions (emulated and actual). After participants complete the procedures detailed above, they may be eligible to be invited to participate in follow-up phone interviews. A subset of participants may also be invited to participate in follow-up biomechanical data collection comparing the PFE foot conditions to the respective actual prosthetic feet during walking. Additionally, a subset of participants may also be invited to participate in follow-up data collection comparing prosthetic foot conditions of different stiffness categories.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Robotic Emulation of Candidate Prosthetic Foot Designs May Enable Efficient, Evidence-Based, and Individualized Prescriptions.
   Caputo JM, Dvorak E, Shipley K, Miknevich MA, et al · · 2022 · cited 7× · PMID 36157327 · DOI 10.1097/jpo.0000000000000409