Status:
COMPLETED
Using Direct Molding Socket Technology for Trans-tibial Prosthesis in Developing Regions
Lead Sponsor:
Amparo GmbH
Collaborating Sponsors:
GDI Hub
AT 2030
Conditions:
Transtibial Amputees
Eligibility:
All Genders
18+ years
Brief Summary
The study aims to understand how well CPOs and amputees can adapt to using the Amparo socket technology. CPOs at the APDK and The Cure will be trained to use the Amparo socket technology then use it w...
Detailed Description
Objective: The objective of the trial is to ascertain the benefits and the implications of using the Amparo socket technology within the context of two pre-existing prosthetic services in Eastern Afr...
Eligibility Criteria
Inclusion
- Below-Knee amputees 18 years of or older Individuals who would normally receive prosthetic care from the respective organization Minimum of 4 weeks after amputation Able to read and communicate in English User must be able to use a passive valve suspension system with a knee sleeve (Donning the LLP with suspension system require moderate level of hand strength and dexterity)
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Exclusion
- Users who have a known complication e.g. infection, open wounds, etc… Users who weigh more than 125kg (the max usage weight for the product) Users' residual limb cannot be longer than 25cm (MPT to stump end measurement) Users' residual limb cannot have distal circumference larger than 45cm (measured circumference with liner 4cm from end of stump)
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Key Trial Info
Start Date :
July 8 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04679701
Start Date
July 8 2019
End Date
November 30 2020
Last Update
December 22 2020
Active Locations (2)
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1
AIC CURE International Hospital Kenya
Kijabe, Kenya
2
Association for the Physically Disabled of Kenya (APDK)
Mombasa, Kenya, 80100