AmputationNCT04354493
Myoelectric Game Training and Outcomes
A study testing Myo-electric Gaming Interface in people with Amputation and Prosthesis User, run by Liberating Technologies, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of myo-electric training tools on prosthesis functional outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amputation, Prosthesis User, Prosthesis
- What is being tested?
- Myo-electric Gaming Interface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2019to 18 Sep 2022
- 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
- User of upper-limb myo-prosthesis or able to wear prosthesis simulator
- The subjects must be able to read, write, and speak English in order to be properly consented and to express their thoughts to the study personnel, and they must be willing and able to complete the activities outlined in the study.
Who cannot join
- The risks to pregnant people and fetuses are unknown and therefore pregnant individuals should not participate in the study.
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 effects of myo-electric training tools on prosthesis functional outcomes.
Read the detailed description
Participants will undergo informed consent and schedule an initial site visit. A logging device will be used to track activity of prosthetic arm usage while in everyday use at home. After a baseline period, participants will schedule a second visit to be introduced to the training technology.
The study will span up to 7 months with participants training at home for 15-60 minutes, 3-5 times a day. Every 3-6 weeks, investigators will schedule a study event and sit visit to conduct functional outcome tasks and measurements.
- Conditions
- Amputation, Prosthesis User, Prosthesis
- Being tested
- Myo-electric Gaming Interface
- Keywords
- myoelectric, training, upper limb, prosthetics, video games
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-electric Gaming InterfaceDevice
Also called MEGI
Non-significant risk, video game controller which maps myo-electric control signals to button presses.
| Study group | Role | What they receive |
|---|---|---|
| Baseline and Training | Experimental | This group consists of a baseline and training conditions only. Receives: Device: Myo-electric Gaming Interface |
| Baseline, Training, and Control | Experimental | This group stops training condition sooner and returns to a control to evaluate carry-over effects. Receives: Device: Myo-electric Gaming Interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
South Hampton Hand Assesment
Hand functional test
Measured: 6 week periods
Secondary outcomes (2)
Static Tracking Test
Myo-electric reach and hold measure.
Measured: 6 week periods
Dynamic Tracking Test
Myo-electric signal path tracing.
Measured: 6 week periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start4 Apr 2019
- Primary completion18 Sep 2022
- Study completion18 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies 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
- Parallel groups
- Model description
- Two-group study with same baseline and intervention. One group ceases intervention and returns to control condition.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liberating Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354493
- Sponsor's protocol ID
- A-20729
- Other IDs
- 120180273
- Status last verified
- Oct 2022
- First submitted
- 17 Apr 2020
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myoelectric Game Training and Outcomes
- ClinicalTrials.gov ID
- NCT04354493
- Acronym / sponsor ID
- A-20729
- Conditions
- Amputation, Prosthesis User, Prosthesis
- Keywords
- myoelectric, training, upper limb, prosthetics, video games
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Liberating Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 18 Sep 2022 (actual)
- Study completion
- 18 Sep 2022 (actual)
- First posted
- 21 Apr 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 effects of myo-electric training tools on prosthesis functional outcomes.
Detailed description
Participants will undergo informed consent and schedule an initial site visit. A logging device will be used to track activity of prosthetic arm usage while in everyday use at home. After a baseline period, participants will schedule a second visit to be introduced to the training technology.
The study will span up to 7 months with participants training at home for 15-60 minutes, 3-5 times a day. Every 3-6 weeks, investigators will schedule a study event and sit visit to conduct functional outcome tasks and measurements.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-group study with same baseline and intervention. One group ceases intervention and returns to control condition.
| Arm | Type | Receives |
|---|---|---|
| Baseline and Training | Experimental | Device: Myo-electric Gaming InterfaceThis group consists of a baseline and training conditions only. |
| Baseline, Training, and Control | Experimental | Device: Myo-electric Gaming InterfaceThis group stops training condition sooner and returns to a control to evaluate carry-over effects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- User of upper-limb myo-prosthesis or able to wear prosthesis simulator
- The subjects must be able to read, write, and speak English in order to be properly consented and to express their thoughts to the study personnel, and they must be willing and able to complete the activities outlined in the study.
Key exclusion criteria (1 listed)
- The risks to pregnant people and fetuses are unknown and therefore pregnant individuals should not participate in the study.
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 |
|---|---|---|
| Myo-electric Gaming InterfaceAlso: MEGINon-significant risk, video game controller which maps myo-electric control signals to button presses. | Device | Baseline and Training, Baseline, Training, and Control |
Primary outcome
South Hampton Hand Assesment
Time frame: 6 week periods
Hand functional test
2 secondary outcomes
Static Tracking Test
Time frame: 6 week periods
Dynamic Tracking Test
Time frame: 6 week periods
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 19 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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 testing Myo-electric Gaming Interface in people with Amputation and Prosthesis User, 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 2 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 19 Oct 2022. 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?
South Hampton Hand Assesment (time frame: 6 week periods). 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 19 Oct 2022.