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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04936789
Other study ID # CIP2020072116
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2021
Est. completion date September 2024

Study information

Verified date June 2021
Source Össur Ehf
Contact Daire McGuinness, BSc
Phone 00441315070097
Email dmcguinness@ossur.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
IMES
Surgical implantation of IMES

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Össur Ehf

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
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.
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