Clinical Feasibility of the IMES Transradial Prosthesis

Össur Iceland ehf3 enrolled

Overview

This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control a transradial prosthesis

The study assesses the feasibility of an implantable myoelectric prosthesis control system to control a transradial prosthesis. 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 up to 16 IMES into residual forearm muscles, subjects will begin a two week training phase. When they receive their custom-fit IMES Transradial Prosthesis (including electromechanical wrist and hand) subjects initiate approximately four months of home use. Subjects will be offered up to five post-study follow-up visits. The usability and functionality of the prosthetic system will be evaluated throughout the study.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Amputation

Interventions

IMESDEVICE

Surgical implantation of IMES

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * (unilateral acquired transradial) amputation * residual limb size requirements to fit investigational device componentry * at least 6 residual muscle locations available for implantation * good compliance with health service (rehabilitation) * willing to undergo surgical implantation of IMES Sensor implants * experience with myoelectric upper limb prostheses * using own myoelectric device approximately 6-8h/day * able to provide informed consent and attend the study visits Exclusion Criteria: * any condition which in the opinion of the investigator poses a risk to health * neurological disorder that may prohibit accurate control * major injury proximal to the level of amputation * neuromuscular disorder * nerve transection or palsy that may cause de-innervation of muscles planned for implantation * allergy to implanted materials * existing active implant

Locations (1)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Grip Accuracy

Self-drafted assessment of accuracy in prosthesis movements. The purpose of this measure is to quantify subjects' ability to use the investigational device to control specific prosthetic movements. When performing the Accuracy Test, the subject attempts to execute a series of specified wrist and hand movements using the investigational device. An objective rater scores each movement on a 0-3 scale with 0 = no movement observed and and 3 = movement observed (with no unintended movements). A score is given for each movement and a combined score is derived from the complete set of movements. Administered as a repeated measure, the Grip Accuracy test assesses Change over time (training effect).

Time frame: The measure will be carried out 11 times during the study, at Baseline with the subject's own device for comparison, and at 10 study visits with the investigational device conducted over approximately 6 months.

Central Contacts

Daire McGuinness, BSc

CONTACT

00441315070097 dmcguinness@ossur.com

Data from ClinicalTrials.gov

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