Clinical trial NCT04595071: Functional Outcomes of Voice Recognition Prosthesis
Official title: Functional Outcomes of Voice Recognition Prosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthesis
Amputation
Prosthesis User
Keywords: voice recognition
prosthetics
upper limb
Lead sponsor: Liberating Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-10-20
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Voice-Activated Prosthesis Interface
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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.

Primary outcomes:
measure: University of New Brunswick (UNB) Test of Prosthetics Function
timeFrame: 2 Days
Secondary outcomes:
measure: Custom Activities of Daily Living (ADL) Tasks
timeFrame: 2 Days
measure: Grip Switch Assessment (GSA)
timeFrame: 2 Days
Other outcomes:
measure: Missed grips
timeFrame: 2 Days
Locations:
city: Holliston
country: United States
facility: Liberating Technologies, Inc.
state: Massachusetts
Study officials:
References: