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Led by Seattle Institute for Biomedical and Clinical Research · Updated on 2025-09-08
100
Participants Needed
2
Research Sites
N/A
Total Duration
Researchers are evaluating how different prosthetic feet affect stability and fall-related outcomes in Veterans with below-knee leg amputations. The study aims to improve understanding of how a customizable robotic prosthetic foot emulator PFE can help predict which commercial prosthetic feet best support stability, balance confidence, and functional mobility. This research focuses on optimizing prosthetic prescription strategies to enhance quality of life and reduce falls for people with lower leg amputations. Participants will use the multiaxial Prosthetic Foot Emulator, which mimics the mechanical properties of various commercial prosthetic feet, during walking tests on different surfaces like inclines and uneven ground. The study involves a randomized, participant-blinded crossover design where Veterans will test three different foot modes with the PFE and three corresponding actual commercial prosthetic feet. After initial testing, participants will wear each commercial foot at home and in the community for about one week before switching to the next foot. During up to six study visits, participants will complete walking tests, self-report surveys, and performance-based assessments such as the Narrowing Beam Walking Test and Four Square Step Test. Researchers will measure perceived stability, balance confidence, and biomechanical stability outcomes. The study includes both laboratory assessments and real-world use of prosthetic feet, with follow-up testing to evaluate longer-term effects. Total study participation spans multiple weeks with repeated measurements to capture comprehensive stability and functional outcomes.
CONDITIONS
A Prosthetic Foot Test-Drive Strategy for Improving Stability in Veterans With Leg Amputations
D
David C Morgenroth, MD
E
Elizabeth G Halsne, PhD, CPO
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Seattle Institute for Biomedical and Clinical Research
Lead Sponsor
VA Puget Sound Health Care System
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | PFE (Investigational Foot Emulator) | Commercial Prosthetic Feet (Current Options) |
|---|---|---|
| What is it? | An investigational foot device that emulates multiaxial movement during walking, allowing users to test different types of prosthetic foot dynamics and stiffness in a controlled environment. | A selection of widely used, commercially available prosthetic feet provided to participants for both laboratory-based and take-home walking, reflecting standard device options in current clinical use. |
| Role in the trial | Tested under controlled laboratory conditions to evaluate stability, balance confidence, and user preferences while walking with varying foot characteristics. | Participants use standard prosthetic feet in the lab and at home as the active comparison condition, providing baseline and real-world measures of stability and satisfaction. |
| Primary use | To simulate and evaluate the performance and user experience of different multiaxial prosthetic foot characteristics prior to clinical prescription. | To provide stable, functional walking for individuals with below-knee amputation in both clinical and daily life settings, consistent with common prosthetic practice. |
| How is it given or performed? | Participants walk in a laboratory setting using the emulator with multiple foot mode settings. Testing is conducted on various surfaces and walking speeds. | Participants walk in the laboratory and use the commercial prosthetic foot at home and in daily activities for about a week. Follow-up evaluations occur after use. |
| Evidence status | Effectiveness for improving stability and satisfaction is under investigation in this clinical trial. No published clinical outcome evidence available yet. | Commercial prosthetic feet are standard options with established use and published studies supporting their safety and functional outcomes for walking and stability in similar populations. |
| Important limitations | Findings from laboratory-based walking with the foot emulator may not fully predict long-term real-world use or personal device selection, as real-life adaptation and durability are not assessed in the same way. | Users' individual preferences, residual limb characteristics, and activity demands may influence the optimal choice of commercial prosthetic foot, making generalization of study results more complex. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 1 day
Participants walk in the laboratory with the multiaxial Prosthetic Foot Emulator (PFE) in three modes that mimic commercial prosthetic feet under various walking conditions including different speeds, inclines, cross slopes, and uneven terrain.
1 laboratory visit (approximately 2 hours)
Duration - Approximately 3 weeks total (1 week per commercial foot)
Participants walk in the laboratory with three different commercial prosthetic feet under the same walking conditions as with the emulator. Participants are then fit with one of the commercial feet to wear at home and in the community for about one week. This process is repeated for each commercial foot.
3 laboratory visits and community wear periods (approximately 2 hours each laboratory visit, plus home wear)
Duration - Concurrent with the testing period and after each community wear week
Participants return to the laboratory for follow-up testing after each community wear period to assess stability, balance confidence, and functional outcomes using the commercial prosthetic feet.
3 follow-up laboratory visits (approximately 2 hours each)
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Tyler K Ho, Elizabeth G Halsne, Sara R Koehler-McNicholas...
https://pubmed.ncbi.nlm.nih.gov/41124130/Seattle Institute for Biomedical and Clinical Research
Lead Sponsor
VA Puget Sound Health Care System
Collaborating Sponsor
