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NCT04354493 Clinical Trial

Myoelectric Game Training and Outcomes

Amputation Clinical Trial

Official title:
Myoelectric Game Training and Outcomes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04354493
Other study ID # A-20729
Secondary ID 120180273
Status Completed
Phase N/A
First received
Last updated
Start date April 4, 2019
Est. completion date September 18, 2022

Study information
Verified date October 2022
Source Liberating Technologies, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date September 18, 2022
Est. primary completion date September 18, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Myo-electric Gaming Interface
Non-significant risk, video game controller which maps myo-electric control signals to button presses.

Locations
Country Name City State
United States Liberating Technologies Inc. Holliston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Liberating Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary South Hampton Hand Assesment Hand functional test 6 week periods
Secondary Static Tracking Test Myo-electric reach and hold measure. 6 week periods
Secondary Dynamic Tracking Test Myo-electric signal path tracing. 6 week periods
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