Status:
UNKNOWN
Evaluation of High-Performance, Customized, Rapidly-Manufacturable Prosthetic Feet That Provide Improved Mobility
Lead Sponsor:
Massachusetts Institute of Technology
Collaborating Sponsors:
Hanger Clinic: Prosthetics & Orthotics
Conditions:
Amputation of Lower Limb Below Knee
Eligibility:
All Genders
18-65 years
Brief Summary
The purpose of this research is to design a high-performance, customized, and rapidly- manufacturable passive prosthetic foot for use in the United States. We are currently testing an early stage prot...
Detailed Description
The purpose of this research is to design a high-performance, customized, and rapidly- manufacturable passive prosthetic foot for use in the United States. We are currently testing an early stage prot...
Eligibility Criteria
Inclusion
- Unilateral transtibial amputation
- Aged between 18-65 years
- Body mass index between 18.5-29.9 (healthy weight)
- Daily use of their clinically-prescribed prosthesis for ambulation without an assistive device
- Classified as at least a Medicare Functional Classification Level K3 (defined as a patient who is a typical unlimited community ambulator)
- Experience walking with a prosthesis for at least one year
- Residuum and amputated side in good condition (e.g., no adherent scars, lesions, ulcers, or infections)
- Normal or corrected vision
- Ability to walk continuously for 45 minutes without undue fatigue or health risks.
Exclusion
- Subjects who weigh more than 200 pounds
- Poor fitting prosthetic socket
- Skin problems on the residual limb
- Co-morbidities or pathologies (other than the amputation) or medications that would affect the sound limb, spine, balance, or stability
- Decision by prosthetists at Hanger that walking on the prototype limb may pose higher than minimal risk for a potential subject.
Key Trial Info
Start Date :
March 3 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05265403
Start Date
March 3 2022
End Date
August 31 2022
Last Update
April 12 2022
Active Locations (1)
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1
Hanger Clinic
Salt Lake City, Utah, United States, 84109