Functional Outcomes of Voice Recognition Prosthesis

Amputation Clinical Trial

Official title:

Functional Outcomes of Voice Recognition Prosthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04595071
• Other study ID #: 120180305
• Secondary ID: 1R43HD095750-011
• Status: Completed
• Phase: N/A
• Start date: November 13, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2020
• Source: Liberating Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amputation
• Prosthesis
• Prosthesis User

Intervention

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.

Locations

Country	Name	City	State
United States	Liberating Technologies, Inc.	Holliston	Massachusetts

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Missed grips	A count of the number of intended missed grip changes	2 Days
Primary	University of New Brunswick (UNB) Test of Prosthetics Function	A Test for Unilateral Upper Limb Amputees	2 Days
Secondary	Custom Activities of Daily Living (ADL) Tasks	Timed completion of a set of custom ADL	2 Days
Secondary	Grip Switch Assessment (GSA)	Timed completion of a randomized set of multi-articulating hand grip switches	2 Days

External Links

•   UNB Test of Prosthetics Function