Condition: Amputation · Sponsor: Seattle Institute for Biomedical and Clinical Research
Objective/Hypotheses and Specific Aims: The first aim of this proposal is to determine the effects of commercial prosthetic feet of varying stiffness on stability and falls-related outcomes in Veterans with TTA. The second aim is to determine whether a PFE can be used to predict stability and balance-confidence outcomes with corresponding commercial prosthetic feet. The third and final aim is to determine whether a brief trial of commercial prosthetic feet can predict longer-term stability and balance-confidence outcomes in Veterans with TTA. Study Design: The investigators will use a participant blinded cross-over study with repeated measurements in Veterans and Service members with TTA. Up to 50 participants will be enrolled at each of the two study sites VA Puget Sound and VA Minneapolis. 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 on difference surfaces in the laboratory (cross-slopes, inclines, even, and uneven ground). During visit 3 participants will repeat the procedures in the other condition (e.g., PFE if visit 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 one week. At visit 4 par…
This description comes directly from the study's public registry record.
David C Morgenroth, MD · 206-277-1982 · dmorgen@uw.edu
Elizabeth G Halsne, PhD, CPO · 206-277-1217 · bhalsne@uw.edu
Always discuss trial participation with your own doctor first.
| Minneapolis VA Medical Center | Minneapolis, Minnesota, United States | Not Yet Recruiting |
| VA Puget Sound Health Care System | Seattle, Washington, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05473065