University of Oklahoma Health Sciences Center, O'Donoghue Orthotics & Prosthetics Clinic
Oklahoma City, Oklahoma, 73104, United States
NCT Number: NCT00584103
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.
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Notify Me18 year–89 year
All sexes
Interventional
Not applicable
Oklahoma City, Oklahoma, 73104, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will be fitted with a terminal device with their current prosthesis and evaluated using the NYU trans-radial prosthesis checkout form.
Other names: Standard/Current Prosthesis
Subjects will be fitted with the inexpensive prosthesis model from Prestige Healthcare Technologies. Then the terminal device will be fitted and evaluated using the NYU trans-radial prosthesis checkout form.
Other names: Inexpensive Prosthesis
Time frame: 1 day -- time it takes to take measurements and make observations
University of Oklahoma
Other
Evaluation of an Inexpensive Upper Extremity Prosthesis
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