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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Apply ENABLE sensing pad
DeviceThe developed ENABLE system is integrated into the standard prosthetic liner and measures the pressure distribution during locomotion. Using the ENABLE system may lead temporary increase in the temperature inside the prosthetic socket and it is expected that the total exposition during the experimental procedure will be less than 10 min.
Insert small pads at pressure tolerant locations
DeviceTo change the pressure distribution inside the socket, four fitting conditions are introduced by adding small pads at patella tendon (PT), lateral tibial crest (LTC), medial tibial crest (MTC), and popliteal fossa (PF) respectively. Including the no pads scenario, totally of five fitting conditions are simulated.
Treatment groups
3 Participants
are divided into 1 treatment groupGroup A: Transtibial patientExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Discomfort chart
Subjects are requested to fill a Wong-Baker Faces Pain Rating Scale to describe any discomfort experienced when the ENABLE system is used. This data will be used to validate that the ENABLE system is safe to use.
Time frame
The outcome is to evaluate the comfort of the final visit for the project (4 hours).Secondary outcomes
1
Pressure distribution on the residual limb
This outcome is measured by the developed ENABLE system and recorded by cameras after each walking trial. In three of these trials a commercially available pressure sensing pad, is also used to record the pressure distribution in the form of analog readings.
Time frame
The outcome is to evaluate the real pressure on the residual limb in ten 60-second walking trials.Sponsors and contacts
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Source ClinicalTrials.gov