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Functional Outcomes of Voice Recognition Prosthesis

L

Liberating Technologies

Status

Completed

Conditions

Amputation
Prosthesis
Prosthesis User

Treatments

Device: Voice Activated Prosthetic Interface (VAPI) Controller

Study type

Interventional

Funder types

Industry
NIH

Identifiers

NCT04595071
120180305 (Other Identifier)
1R43HD095750-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Device Feasibility

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

4 participants in 2 patient groups

Standard Control
No Intervention group
Description:
Use of standard two-site myoelectric control of multi-articulating hand.
Voice Recognition Control
Experimental group
Description:
Use of voice recognition control in addition to standard two-site myoelectric control of a multi-articulating hand.
Treatment:
Device: Voice Activated Prosthetic Interface (VAPI) Controller

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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