Myoelectric Game Training and Outcomes

NCT ID: NCT04354493

Last Updated: 2022-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-04

Study Completion Date

2022-09-18

Brief Summary

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

Detailed Description

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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

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Amputation Prosthesis User Prosthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-group study with same baseline and intervention. One group ceases intervention and returns to control condition.
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Baseline and Training

This group consists of a baseline and training conditions only.

Group Type EXPERIMENTAL

Myo-electric Gaming Interface

Intervention Type DEVICE

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

Baseline, Training, and Control

This group stops training condition sooner and returns to a control to evaluate carry-over effects.

Group Type EXPERIMENTAL

Myo-electric Gaming Interface

Intervention Type DEVICE

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

Interventions

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Myo-electric Gaming Interface

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

Intervention Type DEVICE

Other Intervention Names

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MEGI

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Liberating Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Liberating Technologies Inc.

Holliston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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120180273

Identifier Type: OTHER

Identifier Source: secondary_id

A-20729

Identifier Type: -

Identifier Source: org_study_id

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