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Functional Outcomes of Voice Recognition Prosthesis

Functional Outcomes of Voice Recognition Prosthesis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04595071
Enrollment
4
Registered
2020-10-20
Start date
2019-11-13
Completion date
2020-06-30
Last updated
2020-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation, Prosthesis, Prosthesis User

Keywords

voice recognition, prosthetics, upper limb

Brief summary

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

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.

Interventions

DEVICEVoice 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.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Liberating Technologies, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Intervention model description

Voice-Activated Prosthesis Interface

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
University of New Brunswick (UNB) Test of Prosthetics Function2 DaysA Test for Unilateral Upper Limb Amputees

Secondary

MeasureTime frameDescription
Custom Activities of Daily Living (ADL) Tasks2 DaysTimed completion of a set of custom ADL
Grip Switch Assessment (GSA)2 DaysTimed completion of a randomized set of multi-articulating hand grip switches

Other

MeasureTime frameDescription
Missed grips2 DaysA count of the number of intended missed grip changes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026