Functional Outcomes of Voice Recognition Prosthesis

Not Applicable

Completed

• Conditions: Amputation; Prosthesis User; Prosthesis

• Registration Number: NCT04595071
• Lead Sponsor: Liberating Technologies, Inc.

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.

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 Timeline

• Study Start: 2019-11-13
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-09
• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-10-14
• Last Update Submitted: 2020-10-14
• Study First Posted: 2020-10-20
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
University of New Brunswick (UNB) Test of Prosthetics Function	2 Days	A Test for Unilateral Upper Limb Amputees

Secondary Outcome Measures

Name	Time	Method
Custom Activities of Daily Living (ADL) Tasks	2 Days	Timed completion of a set of custom ADL
Grip Switch Assessment (GSA)	2 Days	Timed completion of a randomized set of multi-articulating hand grip switches

Trial Locations

Locations (1)

Liberating Technologies, Inc.; 🇺🇸 Holliston, Massachusetts, United States