Clincosm LogoSign in Get a demo

Myoelectric Game Training and Outcomes

Sponsor
Liberating Technologies, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04354493
Collaborator
(none)
6
Enrollment
1
Location
2
Arms
40.9
Anticipated Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effects of myo-electric training tools on prosthesis functional outcomes.

Condition or Disease Intervention/Treatment Phase
  • Device: Myo-electric Gaming Interface
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
6 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two-group study with same baseline and intervention. One group ceases intervention and returns to control condition.Two-group study with same baseline and intervention. One group ceases intervention and returns to control condition.
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Myoelectric Game Training and Outcomes
Actual Study Start Date :
Apr 4, 2019
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. South Hampton Hand Assesment [6 week periods]

      Hand functional test

    Secondary Outcome Measures

    1. Static Tracking Test [6 week periods]

      Myo-electric reach and hold measure.

    2. Dynamic Tracking Test [6 week periods]

      Myo-electric signal path tracing.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Liberating Technologies Inc. Holliston Massachusetts United States 01746

    Sponsors and Collaborators

    • Liberating Technologies, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Liberating Technologies, Inc.
    ClinicalTrials.gov Identifier:
    NCT04354493
    Other Study ID Numbers:
    • A-20729
    • 120180273
    First Posted:
    Apr 21, 2020
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Liberating Technologies, Inc.
    myoelectric
    training
    upper limb
    prosthetics
    video games

    Study Results

    No Results Posted as of Apr 6, 2022