R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment
North Carolina State University
3 participants
Apr 20, 2021
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria5
- 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
- The fibula length on the residual limb must be greater than half of the length of the fibula on the unaffected side
Exclusion Criteria3
- 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
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Interventions
The 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.
To 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.
Locations(1)
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NCT05425810