Functional Outcomes of Voice Recognition Prosthesis
2 other identifiers
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedFirst Submitted
Initial submission to the registry
September 25, 2020
CompletedFirst Posted
Study publicly available on registry
October 20, 2020
CompletedOctober 20, 2020
September 1, 2020
8 months
September 25, 2020
October 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
University of New Brunswick (UNB) Test of Prosthetics Function
A Test for Unilateral Upper Limb Amputees
2 Days
Secondary Outcomes (2)
Custom Activities of Daily Living (ADL) Tasks
2 Days
Grip Switch Assessment (GSA)
2 Days
Other Outcomes (1)
Missed grips
2 Days
Study Arms (2)
Standard Control
NO INTERVENTIONUse of standard two-site myoelectric control of multi-articulating hand.
Voice Recognition Control
EXPERIMENTALUse of voice recognition control in addition to standard two-site myoelectric control of a multi-articulating hand.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Liberating Technologies, Inc.
Holliston, Massachusetts, 01746, United States
Related Links
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2020
First Posted
October 20, 2020
Study Start
November 13, 2019
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
October 20, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share