R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment
Recruiting now · Not applicable
Conditions studied: Lower Limb Amputation Below Knee (Injury)
In brief
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.
Key facts
- Study ID
- NCT05425810
- Run by
- North Carolina State University
- People needed
- 3
- Starts
- 2021-04-20
- Expected to finish
- 2026-02-27
- Last updated by the study team
- 2025-05-20
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- NC State University — Raleigh, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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