Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4 participants
INTERVENTIONAL
2019-11-13
2020-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Standard Control
Use of standard two-site myoelectric control of multi-articulating hand.
No interventions assigned to this group
Voice Recognition Control
Use of voice recognition control in addition to standard two-site myoelectric control of a multi-articulating hand.
Voice Activated Prosthetic Interface (VAPI) Controller
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.
Interventions
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Voice Activated Prosthetic Interface (VAPI) Controller
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Liberating Technologies, Inc.
INDUSTRY
Responsible Party
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Locations
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Liberating Technologies, Inc.
Holliston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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UNB Test of Prosthetics Function
Other Identifiers
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120180305
Identifier Type: OTHER
Identifier Source: secondary_id
120180305
Identifier Type: -
Identifier Source: org_study_id
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