ProsthesisNCT04595071
Functional Outcomes of Voice Recognition Prosthesis
A study of Prosthesis and Amputation, run by Liberating Technologies, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prosthesis, Amputation, Prosthesis User
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Liberating Technologies, Inc.
Holliston, Massachusetts, 01746
About this study
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.
Read the 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.
- Conditions
- Prosthesis, Amputation, Prosthesis User
- Being tested
- Voice Activated Prosthetic Interface (VAPI) Controller
- Keywords
- voice recognition, prosthetics, upper limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice Activated Prosthetic Interface (VAPI) ControllerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Voice Activated Prosthetic Interface (VAPI) Controller |
What is being measured
The primary outcome is the main question the study is designed to answer.
University of New Brunswick (UNB) Test of Prosthetics Function
A Test for Unilateral Upper Limb Amputees
Measured: 2 Days
Secondary outcomes (2)
Custom Activities of Daily Living (ADL) Tasks
Timed completion of a set of custom ADL
Measured: 2 Days
Grip Switch Assessment (GSA)
Timed completion of a randomized set of multi-articulating hand grip switches
Measured: 2 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start13 Nov 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProsthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Voice-Activated Prosthesis Interface
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liberating Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595071
- Sponsor's protocol ID
- 120180305
- Other IDs
- 1R43HD095750-01, 120180305
- Status last verified
- Sep 2020
- First submitted
- 25 Sep 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes of Voice Recognition Prosthesis
- ClinicalTrials.gov ID
- NCT04595071
- Acronym / sponsor ID
- 120180305
- Conditions
- Prosthesis, Amputation, Prosthesis User
- Keywords
- voice recognition, prosthetics, upper limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Liberating Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Voice-Activated Prosthesis Interface
| Arm | Type | Receives |
|---|---|---|
| Standard Control | No intervention | –Use of standard two-site myoelectric control of multi-articulating hand. |
| Voice Recognition Control | Experimental | Device: Voice Activated Prosthetic Interface (VAPI) ControllerUse of voice recognition control in addition to standard two-site myoelectric control of a multi-articulating hand. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice Activated Prosthetic Interface (VAPI) ControllerA 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. | Device | Voice Recognition Control |
Primary outcome
University of New Brunswick (UNB) Test of Prosthetics Function
Time frame: 2 Days
A Test for Unilateral Upper Limb Amputees
2 secondary outcomes
Custom Activities of Daily Living (ADL) Tasks
Time frame: 2 Days
Grip Switch Assessment (GSA)
Time frame: 2 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- UNB Test of Prosthetics FunctionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Prosthesis and Amputation, run by Liberating Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
University of New Brunswick (UNB) Test of Prosthetics Function (time frame: 2 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020; AzTrials last refreshed its copy on 27 Oct 2026.