Status:
COMPLETED
Low Cost Socket for Lower Limb Amputees
Lead Sponsor:
Shirley Ryan AbilityLab
Conditions:
Amputation
Amputation; Traumatic, Limb
Eligibility:
All Genders
18-95 years
Phase:
NA
Brief Summary
The purpose of this research is to test an investigational fabrication system for transtibial prostheses. This fabrication method will be tested for comfort and function to determine feasibility of us...
Detailed Description
Millions of amputees in low-income nations lack access to prosthetic care. Conventional socket fabrication is complex, and the need for prosthetists is far greater than the throughput of existing clin...
Eligibility Criteria
Inclusion
- Unilateral transtibial amputees having had their amputation at least 6 months prior, so that they have a relatively stable conical residual limb shape and can ambulate independently
- Currently has a well-fitting prosthesis- as defined by a self-reported Socket Comfort Score of at least a 6 out of 10
- K2, K3, K4 level ambulators
- Understands the English language
Exclusion
- Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate usable, reliable data. The ability to obtain relevant user feedback and informal discussion adds significant value to this study.
- Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study (e.g stroke, pacemaker placement, etc), or that would otherwise prevent acquisition of usable data by researchers.
- Bulbous residual limb shape causing inability to fit within system restrictions
- Open wounds on the residual limb
- Inability to understand the English language
Key Trial Info
Start Date :
July 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2025
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04725461
Start Date
July 6 2018
End Date
January 1 2025
Last Update
June 17 2025
Active Locations (1)
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1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611