R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorNorth Carolina State University

About this trial

Lower limb amputees (LLA) rely on their prosthetic legs to remain active and lead an independent life. For most LLAs, a well-fitted prosthetic socket is the only option to interface with their prosthetic leg, however, it is a real challenge to make a prosthetic socket to interface with residual limbs accurately. One of the reasons is that there lack of accurate approaches to evaluate the pressure distribution on the residual limb accurately and effectively. To overcome this issue, the research team will develop an innovative sensing system, which permits the prosthetists to track the pressure distribution on the residual limb visually. The capability of the new sensing system will be demonstrated on lower limb amputees.

Eligibility criteria

Qualifiers

Unilateral transtibial amputees

At least 1 year of experience using his/her prosthetic leg

Has used the current socket for at least 6 months without a significant skin issue or major modification

Can comfortably walk 3 mins without pausing to rest

Disqualifiers

Cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the experiments

neuropathy observed on the residual limb

regnant female

Trial design

Treatments tested in this trial

  • Apply ENABLE sensing pad
  • Insert small pads at pressure tolerant locations

Treatment groups

3 Participants
are divided into 1 treatment group