CompletedNot Applicable

Feasibility of Implantable Myoelectric Sensors to Control Upper Limb Prostheses

United States3 participantsStarted 2013-05

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient is a health care beneficiary at the Walter Reed National Military Medical Center.
✓. Patient has transradial amputation with one-third or greater residual forearm length as determined by the contralateral side.
✓. Patient's residual forearm anatomy (based on number and size of residual muscles) will support the implantation and control of at least six IMES (in the opinion of the Investigator). This criterion will be verified during a study-specific screening test.
✓. Patient is age 18 or above.
✓. Patient can speak and comprehend English.
✓. Patient is willing and capable of providing informed consent.
✓. Patient has undergone amputee rehabilitation, including being trained to wear and use a body-powered and myoelectric prosthesis.
✓. Patient reports wearing an upper limb prosthesis at least two hours per day.

Exclusion criteria

✕. Patient is less than three months from amputation surgery or major injury of the target residual limb.
✕. Patient has major injury proximal to the level of amputation.
✕. In the opinion of the Investigator, patient is prone to skin breakdown in the target residual limb.
✕. Known nerve transection or palsy that may cause de-innervation of muscles in the target residual limb.
✕. Known genetic neuromuscular disorder (e.g. multiple sclerosis, myasthenia gravis, muscular dystrophy).
✕. Patient has a bleeding or clotting disorder.
✕. Bilateral upper extremity amputation.
✕. Patient has a major psychological disorder such as poorly controlled PTSD, schizophrenia, or paranoia such that cooperative status is inconsistent.

What they're measuring

Device-Related Serious Adverse Events

Timeframe: Information collected over the course of 2 years following implant of IMES

Change in Accuracy Test score

Timeframe: 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

Trial details

NCT IDNCT01901081

SponsorThe Alfred E. Mann Foundation for Scientific Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12

View on ClinicalTrials.gov More Amputation, Traumatic trials