Transradial Amputation Clinical Trial
Official title:
Evaluation of an Inexpensive Upper Extremity Prosthesis
The purpose of this study is to evaluate a design of prosthesis that is inexpensive and able to fit a multitude of individuals. This may offer an off the shelf item for those that cannot afford a customized prosthesis, or wish to have an inexpensive spare.
A prospective study will be done on an inexpensive below elbow upper extremity prosthesis.
Prestige Healthcare Technologies Ltd. has developed a prosthesis that is easily and
inexpensively fabricated. The prosthesis is similar to a fitting frame used by some
prosthetists in trial fits to ensure proper length and angulation of the terminal device.
The prosthesis consists of two pieces of aluminum bar stock running midline the length of
the residual limb. One bar is located anteriorly, the other posteriorly. A terminal device
will be placed in the receiver on the distal end of the prosthesis. An aluminum band will
connect the anterior and posterior bar stock for structural stability. A finished figure of
eight harness will be utilized for control and suspension of the prosthesis. The research
performed will be noninvasive. The check out will be based on the New York University (NYU)
trans-radial prosthesis checkout form. Prestige Healthcare Technologies has donated an adult
size trans-radial prosthesis to be utilized for this study.
Each patient will serve as their own control group. The control group will be considered
using the same guidelines for testing function of the patient's current prosthesis, which we
will refer to as alpha P. The patient will then be fitted with the inexpensive model, which
we will refer to as beta P. The results will be compared to the NYU standard as well as
comparing between the results of alpha P and beta P. Beta P will be the same prosthesis
personalized for subjects with the harness adjusted to properly fit each individual.
The benefit of this study may provide an inexpensive versatile alternative to the current
below elbow prosthesis. This version may be utilized as a spare prosthesis while the patient
is unable to use his primary prosthesis.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04522349 -
Compensatory Movements With Axon-Hook and Greifer in Transradial Amputees
|
N/A |