Myoelectric Game Training and Outcomes

Not Applicable

Completed

• Conditions: Prosthesis; Prosthesis User; Amputation
• Interventions: Device: Myo-electric Gaming Interface

• Registration Number: NCT04354493
• Lead Sponsor: Liberating Technologies, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2019-04-04
• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-21
• Primary Completion: 2022-09-18
• Study Completion: 2022-09-18
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baseline, Training, and Control	Myo-electric Gaming Interface	This group stops training condition sooner and returns to a control to evaluate carry-over effects.
Baseline and Training	Myo-electric Gaming Interface	This group consists of a baseline and training conditions only.

Primary Outcome Measures

Name	Time	Method
South Hampton Hand Assesment	6 week periods	Hand functional test

Secondary Outcome Measures

Name	Time	Method
Static Tracking Test	6 week periods	Myo-electric reach and hold measure.
Dynamic Tracking Test	6 week periods	Myo-electric signal path tracing.

Trial Locations

Locations (1)

Liberating Technologies Inc.; 🇺🇸 Holliston, Massachusetts, United States