A Prosthetic Foot Test-Drive Strategy for Improving Stability in Veterans With Leg Amputat
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 outcome
| Condition(s) | Amputation |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 Minneapoli |
| Who can participate | Inclusion Criteria: * has a unilateral (one leg) transtibial (below-knee) amputation * has used a prosthetic limb for walking for at least six months * has a comfortably fitting prosthetic socket * has a removable prosthetic foot attachment (i.e., is not rigidly attached to the back of the socket) so it can be used with study prosthetic feet * be able to walk with a prosthetic limb sufficiently to participate in the experiment walking trials Exclusion Criteria: * contralateral limb or upper limb amputation that would interfere with completion of study activities * are unable to use more than one of the test feet for any reason (e.g., excessively long residual limb that is not compatible with wearing study prosthetic feet) * unable to walk under the minimal necessary study walking condition |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Lead sponsor | Seattle Institute for Biomedical and Clinical Research |
| Locations | Minneapolis, Minnesota, United States; Seattle, Washington, United States |
| Start date | 2024-03-01 |
| NCT ID | NCT05473065 |
| Official listing | https://clinicaltrials.gov/study/NCT05473065 |