This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control an electromechanical prosthetic wrist and hand.
The study assesses the feasibility of an advanced prosthesis control system aimed at development of a more intuitive and functional prosthetic device. Tiny (2.5 mm by 16 mm) Implantable Myoelectric Sensors (IMES) will be implanted into the residual forearm muscles of three transradial amputee subjects. These devices wirelessly transmit electrical muscle signals to an electromechanical prosthetic wrist and hand. Following a two-week recovery from implantation of six to eight IMES into residual forearm muscles, subjects will initiate seven months of training. Subjects first train for approximately a month using a bench-top IMES system. When they receive their custom-fit IMES Prosthesis (including electromechanical wrist and hand) subjects initiate six months of additional training. Subjects will then be given the option to use the IMES Prosthesis for another sixteen months. The usability and functionality of the prosthetic system will be evaluated throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
3
Once subjects recover from surgical implantation of IMES (approximately two weeks), they will practice IMES control using a bench-top IMES trainer for approximately a month. As soon as the subject's custom-fit IMES Prosthesis is available, it will be fitted and programmed. Subjects will then begin six months of prosthetic training. Month 1 training entails sessions with an Occupational Therapists 4-5 times per week. Months 2-6 Training entail meeting with an Occupational Therapist twice a month. During training, subject will learn how to contract residual musculature in the amputated limb to control movements of an electromechanical wrist and hand. The therapeutic goal is to develop skills needed to perform Activities of Daily Living using the IMES prosthesis. After completing six months of training, subjects will be given the option to continue using their IMES Prosthesis for another sixteen months.
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Device-Related Serious Adverse Events
Tabulation of Device-Related Serious Adverse Events during the course of the study.
Time frame: Information collected over the course of 2 years following implant of IMES
Change in Accuracy Test score
The Accuracy Test requires subjects to execute a series of different hand movements using the IMES to control an electromechanical wrist and hand. Movements are chosen to demonstrate both independent and simultaneous control over the six different movements offered by the prosthesis: hand open/close, thumb adduct/abduct, wrist supinate/pronate. An occupation therapist will score the subject on each movement as follows: 0 = no movement observed; 1 = the intended movement was not observed, but unintended movements were observed; 2 = the intended movement was observed, in addition to unintended movements; 3 = the intended movement was observed. The change in Accuracy Scores across the nine tests completed will be presented. During the Accuracy Test, Electromyographic(EMG) signals transmitted by the IMES will be recorded. A video camera will record the movements of the prosthesis so that this output may be associated with the input IMES signals.
Time frame: test conducted nine times: upon receipt and programming of custom-fit IMES prosthesis; once per month for six months of training; 1 year following implant; and 2 years following implant
Change in Southampton Hand Assessment Procedure (SHAP) test score
The test entails a series of self-timed tasks (the participant starting and stopping the timer with the hand under test), which are divided into two sections: picking and placing eight different shaped objects and performing fourteen Activities of Daily Living (ADL). The objects are shaped to encourage the use of six standard prehensile patterns (spherical, tripod, power, lateral, tip, extension) and come in two different weights to test the participant's ability to form more powerful grips. The fourteen simulated ADLs include cutting, pouring, lifting and transferring loads. Subjects will perform the SHAP test using the IMES to control an electromechanical wrist and hand. Each task is scored based on the amount of time to complete. The change in SHAP scores across the nine tests completed will be presented.
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Time frame: test conducted nine times: upon receipt and programming of custom-fit IMES prosthesis; once per month for six months of training; 1 year following implant; and 2 years following implant
Change in Assessment of Capacity for Myoelectric Control (ACMC) test score
The ACMC is administered and scored based on observations of the subject as he or she is performing an everyday task using the IMES to control an electromechanical wrist and hand. Tasks will be chosen from a selection of six that include: packing a suitcase, sorting mail, mixing a ready-to-eat product, repotting a plant, assembling a ready-made project, and setting a table. During the assessment, subjects are encouraged to accomplish the task spontaneously in their usual way. The occupational therapist assesses capacity for control of the prosthesis by rating the performances on 22 items representing different aspects of control that are classified as gripping, holding, releasing, and coordinating between hands. Each subject's performance is rated with scores ranging from 0 to 3, where 0 = not capable, 1 = sometimes capable, capacity not established, 2 = capable on request, and 3 = spontaneously capable. The change in ACMC Scores across the nine tests completed will be presented.
Time frame: test conducted nine times: upon receipt and programming of custom-fit IMES prosthesis; once per month for six months of training; 1 year following implant; and 2 years following implant
Change in Box and Block Test (BBT) score
The BBT measures unilateral gross manual dexterity. The BBT is composed of a wooden box divided in two compartments and 150 blocks. The subject is asked to move as many blocks as possible from one compartment of a box to another, within 60 seconds. The task is to be performed using the IMES to control an electromechanical wrist and hand. The change in BBT Score across the nine tests completed will be presented.
Time frame: test conducted nine times: upon receipt and programming of custom-fit IMES prosthesis; once per month for six months of training; 1 year following implant; and 2 years following implant
IMES Satisfaction Questionnaire
Subjects will be asked to complete a questionnaire in which they rate and describe their satisfaction with different aspects of the IMES Prosthesis.
Time frame: completed after six months of training following upon receipt and programming of custom-fit IMES prosthesis