Myoelectric Game Training and Outcomes

NCT04354493 | Completed FDA Device

• 2 other identifiers: A-20729120180273
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amputation; Prosthesis User; Prosthesis

Keywords

myoelectric; training; upper limb; prosthetics; video games

Outcome Measures

Primary Outcomes (1)

• South Hampton Hand Assesment

  Hand functional test

  6 week periods

Secondary Outcomes (2)

• Static Tracking Test

  6 week periods

• Dynamic Tracking Test

  6 week periods

Study Arms (2)

Baseline and Training

EXPERIMENTAL

This group consists of a baseline and training conditions only.

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.

Device: Myo-electric Gaming Interface

Interventions

Myo-electric Gaming Interface DEVICE

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

Also known as: MEGI

Baseline and Training; Baseline, Training, and Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Liberating Technologies, Inc.: lead

Study Sites (1)

Liberating Technologies Inc.

Holliston, Massachusetts, 01746, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two-group study with same baseline and intervention. One group ceases intervention and returns to control condition.

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: April 4, 2019
• Primary Completion: September 18, 2022
• Study Completion: September 18, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

US (1)