NCT01901081

Feasibility of Implantable Myoelectric Sensors to Control Upper Limb Prostheses

A Feasibility Study to Assess Safety and Functionality of Implantable Myoelectric Sensors for Upper Extremity Prosthetic Control in Transradial Amputees

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: The Alfred E. Mann Foundation for Scientific Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control an electromechanical prosthetic wrist and hand.

Detailed description

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.

Conditions

• Amputation, Traumatic

Interventions

Type	Name	Description
DEVICE	IMES	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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2013-07-17
• Last updated: 2017-03-01

Locations

1 site across 1 country: United States