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OpenTrials
Completed

NCT Number: NCT04595071

Functional Outcomes of Voice Recognition Prosthesis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liberating Technologies, Inc.

Holliston, Massachusetts, 01746, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Voice Activated Prosthetic Interface (VAPI) Controller

Device

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.

Primary outcomes

  1. University of New Brunswick (UNB) Test of Prosthetics Function

    Time frame: 2 Days

    A Test for Unilateral Upper Limb Amputees

Secondary outcomes

  1. Custom Activities of Daily Living (ADL) Tasks

    Time frame: 2 Days

    Timed completion of a set of custom ADL

  2. Grip Switch Assessment (GSA)

    Time frame: 2 Days

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

Other outcomes

  1. Missed grips

    Time frame: 2 Days

    A count of the number of intended missed grip changes

Sponsors and collaborators

Lead sponsor

Liberating Technologies, Inc.

Industry

Collaborators

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

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 20, 2020
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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