Enhancing Upper Limb Prostheses With Radio Frequency Identification

Study Overview
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Brief Summary
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The purpose of this study is to determine if Radio Frequency Identification (RFID) can lead to greater prosthesis function and control. Subjects are asked to perform specific tasks and actions using the traditional control method, as well as RFID control.

Official Title
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Validation of a Control Method for Upper Limb Myoelectric Prostheses Using Radio Frequency Identification (RFID)

Conditions
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Below Elbow Amputation

Intervention / Treatment
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* Device: Morph


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or greater. Below elbow amputation, unilateral or bilateral. Chronic stable amputation: > 6 months from amputation. Stable prosthesis prescription: > 3 months since last major prosthesis modification. Cognitively intact, as determined by Mini-Mental Status Examination score > 24. Able to provide informed consent and available to participate in study activities. No severe residual limb motor/sensory impairment or pain likely to interfere with treatment. Expected to be medically and psychiatrically stable for study duration. Exclusion Criteria: Patients with diseases which weaken and/or adversely affect the control of skeletal muscle. Patients with poor skin integrity.

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional Assessment<br>Participant will be asked to perform a series of tasks involving their prosthesis. These tasks can involve switching grips as well as moving objects. | Device: Morph<br>* Morph is a small electric controller that is retrofit into existing myoelectric prostheses to equip them with wireless identification capabilities. Specifically, Morph allows the prosthesis to react to RFID tags in the environment.<br>* Other names: Myoelectrically-Operated RFID Prosthetic Hand;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required to perform different functional tasks | Each participant will perform functional tests on the first visit. These tests consist of moving objects from one location to another, and performing certain muscle contraction patterns when prompted. The participant will then take the prosthesis, installed with morph, home for 3 months at most, and then return to perform another set of timed trials. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaires on prosthesis function and satisfaction | The questionnaires offer the participant the opportunity to express their experience and satisfaction with their prosthesis, during different tasks and at home. | 20 minutes per questionnaire, total of 3 different questionnaires administered twice each |