Functional Outcomes of Voice Recognition Prosthesis

October 14, 2020 updated by: Liberating Technologies, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Holliston, Massachusetts, United States, 01746
        • Liberating Technologies, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Control
Use of standard two-site myoelectric control of multi-articulating hand.
Experimental: Voice Recognition Control
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
University of New Brunswick (UNB) Test of Prosthetics Function
Time Frame: 2 Days
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
Time Frame: 2 Days
Timed completion of a set of custom ADL
2 Days
Grip Switch Assessment (GSA)
Time Frame: 2 Days
Timed completion of a randomized set of multi-articulating hand grip switches
2 Days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Missed grips
Time Frame: 2 Days
A count of the number of intended missed grip changes
2 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liberating Technologies, Inc.

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2019

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

September 25, 2020

First Submitted That Met QC Criteria

October 14, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 120180305 (Other Identifier: NEIRB)
  • 1R43HD095750-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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