Clinical Feasibility of the IMES Transradial Prosthesis

Amputation Clinical Trial

Official title:

Clinical Feasibility of the IMES Transradial Prosthesis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04936789
• Other study ID #: CIP2020072116
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Amputation

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.