NCT04595071

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
Last Updated

October 20, 2020

Status Verified

September 1, 2020

Enrollment Period

8 months

First QC Date

September 25, 2020

Last Update Submit

October 14, 2020

Conditions

Keywords

voice recognitionprostheticsupper limb

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 INTERVENTION

Use of standard two-site myoelectric control of multi-articulating hand.

Voice Recognition Control

EXPERIMENTAL

Use of voice recognition control in addition to standard two-site myoelectric control of a multi-articulating hand.

Device: Voice Activated Prosthetic Interface (VAPI) Controller

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.

Voice Recognition Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: Voice-Activated Prosthesis Interface
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

Locations