Status:
RECRUITING
Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1
Lead Sponsor:
North Carolina State University
Collaborating Sponsors:
Arizona State University
University of North Carolina, Chapel Hill
Conditions:
Transfemoral Amputation
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The goal of this clinical trial is to understand the feasibility and effectiveness of using reinforcement learning to personalize robotic prosthetic legs (an experimental prototype) for unilateral tra...
Eligibility Criteria
Inclusion
- Unilateral transfemoral amputees between 18-75 with K level three or higher
- More than one year after amputation
- Using current prosthetic socket and leg for more than three months
- No major skin issues on the residual limb for more than six months
- Can walk for more than 4 minutes continuously without any other assistive devices
Exclusion
- Have very short residual thighs (the length of the residual limb is \<15% of the length of the unimpaired limb)
- Are \<1.50m in height or \>116Kg in weight (who would not fit our prosthesis or the PowerKnee)
- Have cognitive, visual, audio impairments that would affect their ability to give informed consent or to follow simple Instructions during the experiments
- Have any significant co-morbidity that interferes with the study (e.g. stroke, pacemaker placement, pain, etc.).
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2031
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07204925
Start Date
August 1 2025
End Date
October 30 2031
Last Update
October 2 2025
Active Locations (1)
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1
North Carolina State University
Raleigh, North Carolina, United States, 27695