Status:
RECRUITING
R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment
Lead Sponsor:
North Carolina State University
Conditions:
Lower Limb Amputation Below Knee (Injury)
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief 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 prosthe...
Detailed Description
A novel pressure sensing pad will be tested in the project. The purpose of these tests is to collect the safety and efficacy of the sensing pad. The research team would like to seek a Non-significant ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 27 2026
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05425810
Start Date
April 20 2021
End Date
February 27 2026
Last Update
May 20 2025
Active Locations (1)
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1
NC State University
Raleigh, North Carolina, United States, 27695