Trans-Tibial Amputation
Conditions
Brief summary
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.
Interventions
OTHERE-Socket Monitoring
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.
Sponsors
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Prosthesis Users: Aims 1 and 2 * Over 18 years of age * Unilateral or bilateral trans-tibial amputation at least 12 months prior * Have a limb of length 9 cm or greater * Are capable of at least 5 minutes of continuous walking * Regularly use a definitive prosthesis * Do not regularly use assistive devices (e.g., cane, walker) for ambulation * Do not have open wounds on their residual limb at the time of enrollment Aim 2 -Regularly visit their prosthetist at least twice a year,
Exclusion criteria
\- Prosthesis Users: Aims 1 and 2 * Reduced skin sensation * Presence of skin breakdown * Regular use of an assistive device * Persons with trans-femoral amputation Aim 1 Only -Vacuum suspension users
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior-Distal Limb Motion | 12 months | 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. |
Contacts
Primary ContactNick McCarthy
Outcome results
None listed