Feasibility of Implantable Myoelectric Sensors to Control Upper Limb Prostheses

NCT01901081 | Completed

• 1 other identifier: CP0015B
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amputation, Traumatic

Keywords

Implantable Myoelectric Sensor; IMES; transradial; amputation; myoelectric; prosthesis; prosthetic control

Outcome Measures

Primary Outcomes (2)

• Device-Related Serious Adverse Events

  Tabulation of Device-Related Serious Adverse Events during the course of the study.

  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.

  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

Secondary Outcomes (4)

• Change in Southampton Hand Assessment Procedure (SHAP) test score

  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

  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

  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

  completed after six months of training following upon receipt and programming of custom-fit IMES prosthesis

Other Outcomes (3)

• Device Malfunctions

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

• IMES System Usage

  information collected over the course of 6 months following upon receipt and programming of custom-fit IMES prosthesis

• Programming Requirements

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

Study Arms (1)

Prosthetic Training with IMES prosthesis

EXPERIMENTAL

Device: IMES

Interventions

IMES DEVICE

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.

Also known as: Myoelectric Prosthetic Training

Prosthetic Training with IMES prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Unilateral amputation with preserved function of the non-amputated arm; preserved function is investigator opinion as to whether the patient:
• has the ability to independently don and doff a prosthesis,
• has enough dexterity in the non-amputated arm to attach and detach the Prosthetic Control Interface (PCI) cable and operate the PCI power switch,
• has the dexterity to remove and replace the PCI battery.
• Patient is willing and capable of having EMG needles inserted into the forearm.
• In the opinion of the Investigator, patient is cognitively capable of operating an IMES Prosthesis.
• Patient is willing to comply with a wearing schedule for the investigational device.

You may not qualify if:

• 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.
• Patient has an active implant (e.g. pacemaker, implanted cardiac defibrillator \[ICD\], neurostimulator, drug infusion device).
• Patients having any metal fragments or metal implants (e.g. orthopedic hardware) located within the residual forearm are excluded. The absence of metal shall be confirmed by an x-ray of the entire affected arm.
• Patients having metal in the affected upper arm will be considered on a case-by-case basis. An x-ray of the entire affected arm shall be provided to the Sponsor who will assess potential interaction of the metal with the Coil's magnetic field.
• Patient has a history of adverse reactions to anesthetic agents.
• Patient has recently or is currently participating in research that may influence response to either study intervention, or be harmful to the subject in any way.
• A female patient who is pregnant, nursing, or planning to become pregnant during the course of the study.
• In the opinion of the Investigator, the subject is not a suitable candidate for the study, for any reason such as residual limb infection, significant pain, significant proximal nerve injury or soft tissue damage, significant scarring, or poor health of the skin envelope.

Sponsors & Collaborators

• The Alfred E. Mann Foundation for Scientific Research: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

MeSH Terms

Conditions

Amputation, Traumatic

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Paul F Pasquina, MD

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: July 17, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

US (1)