The long-term goal of this research is a socket-embedded prosthesis use and socket fit monitor (E-Socket) that facilitates clinical decision-making in the diagnosis and prognosis of health issues faced by people with transtibial amputation. The overall strategy is to enhance the E-socket to include additional metrics that we identified needed from studies to date (Aim #1). Then we conduct a randomized control trial testing the diagnostic utility of the E-socket data in clinical care (Aim #2). From the data collected in that study, we develop the prognostic capability of the system (Aim #3). Aim 3 will not involve human subject testing as it will focus on the development of the system in preparation for a future aim involving participants' own clinicians. Note: we use the term "diagnostic" throughout our application in a general sense. The device will not be diagnosing specific diseases or medical conditions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
Limb-socket motion data is collected during participant take-home use. Bimonthly telephone interviews are conducted to assess participant residual limb health status. Analysis is conducted to determine if limb motions and activity changes precede limb health changes.
Anterior-Distal Limb Motion
Monitor anterior-distal limb motion in the prosthesis to determine if limb motions and activity changes precede changes in limb health. Interviews with the participants and questionnaires will be used to assess the outcome measure.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.