Clincosm LogoSign in Get a demo

Functional Outcomes of Voice Recognition Prosthesis

Sponsor
Liberating Technologies, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04595071
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
4
Enrollment
1
Location
2
Arms
7.6
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Voice Activated Prosthetic Interface (VAPI) Controller
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Voice-Activated Prosthesis InterfaceVoice-Activated Prosthesis Interface
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Functional Outcomes of Voice Recognition Prosthesis
Actual Study Start Date :
Nov 13, 2019
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. University of New Brunswick (UNB) Test of Prosthetics Function [2 Days]

    A Test for Unilateral Upper Limb Amputees

Secondary Outcome Measures

  1. Custom Activities of Daily Living (ADL) Tasks [2 Days]

    Timed completion of a set of custom ADL

  2. Grip Switch Assessment (GSA) [2 Days]

    Timed completion of a randomized set of multi-articulating hand grip switches

Other Outcome Measures

  1. Missed grips [2 Days]

    A count of the number of intended missed grip changes

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Liberating Technologies, Inc. Holliston Massachusetts United States 01746

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Liberating Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT04595071
Other Study ID Numbers:
  • 120180305
  • 1R43HD095750-01
  • 120180305
First Posted:
Oct 20, 2020
Last Update Posted:
Oct 20, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Liberating Technologies, Inc.
voice recognition
prosthetics
upper limb

Study Results

No Results Posted as of Oct 20, 2020