Status:
COMPLETED
Socket Geometry and Clinical Outcomes of Manual vs Digital Sockets for Lower-limb Amputees
Lead Sponsor:
West Park Healthcare Centre
Conditions:
Amputation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The most important aspect of a lower-limb prosthesis is the socket as the interface between the human and the mechanical prosthetic system. Proper fit of the socket to the residual limb is a critical ...
Detailed Description
This crossover case-control feasibility study aims to explore socket geometries and prosthetic outcomes compared between manually-designed and digitally-designed devices for lower-limb amputees. Feasi...
Eligibility Criteria
Inclusion
- In-patient adults (18 years and older)
- Unilateral transtibial amputation
- Eligible to receive a preparatory prosthetic device
- Able to communicate in English orally and in writing
- Able to tolerate participating in an additional 30- minute 3D scanning session
Exclusion
- Presentation of significant cognitive impairment
- History of epilepsy
- On dialysis at any point of the duration of the study
Key Trial Info
Start Date :
November 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06504303
Start Date
November 10 2021
End Date
November 30 2023
Last Update
July 16 2024
Active Locations (1)
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1
West Park Healthcare Centre
Toronto, Ontario, Canada, M6M 2J5