Myoelectric Game Training and Outcomes

October 17, 2022 updated by: Liberating Technologies, Inc.
The purpose of this study is to evaluate the effects of myo-electric training tools on prosthesis functional outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Holliston, Massachusetts, United States, 01746
        • Liberating Technologies Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • The risks to pregnant people and fetuses are unknown and therefore pregnant individuals should not participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Baseline and Training
This group consists of a baseline and training conditions only.
Device: Myo-electric Gaming Interface
Non-significant risk, video game controller which maps myo-electric control signals to button presses.
Other Names:
  • MEGI
Experimental: Baseline, Training, and Control
This group stops training condition sooner and returns to a control to evaluate carry-over effects.
Device: Myo-electric Gaming Interface
Non-significant risk, video game controller which maps myo-electric control signals to button presses.
Other Names:
  • MEGI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
South Hampton Hand Assesment
Time Frame: 6 week periods
Hand functional test
6 week periods

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Static Tracking Test
Time Frame: 6 week periods
Myo-electric reach and hold measure.
6 week periods
Dynamic Tracking Test
Time Frame: 6 week periods
Myo-electric signal path tracing.
6 week periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liberating Technologies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2019

Primary Completion (Actual)

September 18, 2022

Study Completion (Actual)

September 18, 2022

Study Registration Dates

First Submitted

April 17, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (Actual)

April 21, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A-20729
  • 120180273 (Other Identifier: NEIRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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