Functional Outcomes of Voice Recognition Prosthesis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the use of a voice activated prosthesis interface controller for functional outcomes as compared to standard prosthesis control.

Detailed Description
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The study will take place over two separate visits spaced about 1 week apart. During the first visit participants will undergo informed consent. They will then be randomly assigned one of two test conditions, (a) standard control, or (b) voice recognition control. For both conditions participants will be allowed to train on the control scheme until they are comfortable with it's usage. Subjects will then be asked to manipulate common objects as a test of improved control and utility. Functional outcome measures will be utilized to standardize the tasks performed and evaluate the advantages of voice control. On the second visit participants will be assigned the alternate condition, allowed to train with the control scheme, and run through the same set of functional outcomes measures. Upon completion of the second visit participants will be asked to fill out a questionnaire.

Official Title
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Functional Outcomes of Voice Recognition Prosthesis

Conditions
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Prosthesis, Amputation, Prosthesis User

Intervention / Treatment
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* Device: Voice Activated Prosthetic Interface (VAPI) Controller


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be 18 years or older Be willing and able to complete the tasks outlined in the study Are at least 6 months post amputation Have used an upper limb myo-prosthesis Necessary prosthesis components to interface to the proposed device Have no injury to the residual limb or shoulder that will impact their participation in this study Must be current users of upper limb myo-prosthesis or able to wear a prosthesis simulator brace Users who utilize multi-articulating hand terminal devices, and specifically Touch Bionics iLimb or Steeper beBionic hand users will be preferred, as these are the targeted devices that will be used during testing. Subjects must also be able to speak English in order to be properly consented as well as to interface with the voice recognition module (only English will be included in this feasibility study). Exclusion Criteria: The risks to pregnant people and fetuses are unknown and therefore pregnant people should not participate in the study and will be screened by self-disclosure.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Voice-Activated Prosthesis Interface
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Control<br>Use of standard two-site myoelectric control of multi-articulating hand. | |
| Experimental: Voice Recognition Control<br>Use of voice recognition control in addition to standard two-site myoelectric control of a multi-articulating hand. | Device: Voice Activated Prosthetic Interface (VAPI) Controller<br>* A device installed between a subjects socket quick disconnect wrist connection and multi-articulating hand which enables the use of voice as a control modality in addition to their standard two-site myoelectric control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| University of New Brunswick (UNB) Test of Prosthetics Function | A Test for Unilateral Upper Limb Amputees | 2 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Custom Activities of Daily Living (ADL) Tasks | Timed completion of a set of custom ADL | 2 Days | 
| Grip Switch Assessment (GSA) | Timed completion of a randomized set of multi-articulating hand grip switches | 2 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prosthetics, voice recognition, upper limb