Phase
Condition
N/ATreatment
Hand Casting
Symphonie Aqua SystemTM
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
unilateral lower limb amputation (transtibial and transfemoral)
current prosthesis users
Exclusion
Exclusion Criteria:
poor residual limb sensation
a superficial neuroma that is painful to pressure
an open sore on the residual limb
a residual limb circumference or body weight that exceeds the size or weight limitsof the Symphonie Aqua SystemTM (i.e., >58cm and 170kg for persons with transtibialamputation and >78cm and 170kg for persons with transfemoral amputation
persons who are unable to stand for the 4-6 minutes required for casting (e.g.persons with bilateral amputations).
persons with new amputations (i.e., have been an amputee for less than 1 year)
persons with transfemoral amputation who have a known silicone allergy or a femurlength less than 5 inches
Study Design
Study Description
Connect with a study center
INAIL
Bologna, Emilia-Romagna 40139
ItalySite Not Available
NUPOC
Chicago, Illinois 60611
United StatesSite Not Available
Minneapolis VA Heath Care System
Minneapolis, Minnesota 55417
United StatesSite Not Available
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