Myoelectric Game Training and Outcomes

Study Overview
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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.

Official Title
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Myoelectric Game Training and Outcomes

Conditions
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Amputation, Prosthesis User, Prosthesis

Intervention / Treatment
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* Device: Myo-electric Gaming Interface


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-group study with same baseline and intervention. One group ceases intervention and returns to control condition.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baseline and Training<br>This group consists of a baseline and training conditions only. | Device: Myo-electric Gaming Interface<br>* Non-significant risk, video game controller which maps myo-electric control signals to button presses.<br>* Other names: MEGI;|
| Experimental: Baseline, Training, and Control<br>This group stops training condition sooner and returns to a control to evaluate carry-over effects. | Device: Myo-electric Gaming Interface<br>* Non-significant risk, video game controller which maps myo-electric control signals to button presses.<br>* Other names: MEGI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| South Hampton Hand Assesment | Hand functional test | 6 week periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static Tracking Test | Myo-electric reach and hold measure. | 6 week periods | 
| Dynamic Tracking Test | Myo-electric signal path tracing. | 6 week periods | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myoelectric, training, upper limb, prosthetics, video games