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OpenTrials
Completed

NCT Number: NCT04354493

Myoelectric Game Training and Outcomes

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

Completed

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Key information

Conditions

Amputation Prosthesis Prosthesis User

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liberating Technologies Inc.

Holliston, Massachusetts, 01746, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Myo-electric Gaming Interface

Device

Non-significant risk, video game controller which maps myo-electric control signals to button presses.

Other names: MEGI

Primary outcomes

  1. South Hampton Hand Assesment

    Time frame: 6 week periods

    Hand functional test

Secondary outcomes

  1. Static Tracking Test

    Time frame: 6 week periods

    Myo-electric reach and hold measure.

  2. Dynamic Tracking Test

    Time frame: 6 week periods

    Myo-electric signal path tracing.

Sponsors and collaborators

Lead sponsor

Liberating Technologies, Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2020
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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