People with leg amputations often experience daily changes in the size (volume) of their residual limb. These daily changes can cause a prosthesis to fit poorly. They can also cause limb problems like pain or skin breakdown. Prosthetic socket systems that accommodate limb volume changes can help address these issues, but they require users to make adjustments throughout the day. The aim of this research is to create a system that will automatically adjust the fit of the socket and create a well-fitting prosthesis for people with leg amputations who experience volume fluctuations when using their prosthesis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
100
Participants will test the auto adjusting prosthesis. The prosthesis will be able to move up to 3 panels built into the socket walls to expand or tighten the socket's fit. The auto adjustments will take place during periods of sitting, standing, or walking. Manual adjustments will also be possible either via the researcher controlling the prosthesis or via the key fob developed in the first aim.
William H. Foege Hall
Seattle, Washington, United States
RECRUITINGSocket Comfort Score
Participants in Aim 2 and Aim 3 will test various configurations of the auto adjustment algorithm. Socket comfort score will be asked at various time points during testing, and overall changes in this metric will be calculated from the start and end of session.
Time frame: through study completion, an average of 1 year
Integral Absolute Error of Control System
Calculated error will be measured through each test session, both in and out of lab.
Time frame: through study completion, an average of 1 year
Thermal Recovery Time (TRT)
An infrared (IR) camera will measure residual limb thermal recovery time at the beginning and end of testing--following at least 5 minutes of walking.
Time frame: through study completion, an average of 1 year
Percent change in Limb Fluid Volume
Participant's limb fluid volume will be measured during the structured in-lab protocol (Aim 2), and changes will be compared against an initial reference point of activity during which no interventions will take place.
Time frame: through study completion, an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.