Myoelectric Game Training and Outcomes

Liberating Technologies

Status: Completed

Conditions: Amputation; Prosthesis; Prosthesis User

Treatments: Device: Myo-electric Gaming Interface

Study type: Interventional

Funder types: Industry

Identifiers

NCT04354493

120180273 (Other Identifier)

A-20729

Details and patient eligibility

About

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

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Baseline and Training

Experimental group

Description:

This group consists of a baseline and training conditions only.

Treatment:

Device: Myo-electric Gaming Interface

Baseline, Training, and Control

Experimental group

Description:

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

Treatment:

Device: Myo-electric Gaming Interface