Clinical Feasibility of the IMES Transradial Prosthesis

NCT04936789 | Recruiting

• 1 other identifier: CIP2020072116
• 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 a transradial prosthesis

Conditions

Amputation

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Single arm

EXPERIMENTAL

Single arm. All subjects will receive the intervention. Comparator device will be subjects' own prosthesis at baseline.

Device: IMES

Interventions

IMES DEVICE

Surgical implantation of IMES

Single arm

Eligibility Criteria

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

You may qualify if:

• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Össur Iceland ehf: lead

Study Sites (1)

NHS Greater Glasgow and Clyde

Glasgow, 0000 000, United Kingdom

RECRUITING

Study Officials

• Aidan Roche, MD

  NHS; University of Edinburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daire McGuinness, BSc

CONTACT

00441315070097; dmcguinness@ossur.com

Study Design

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

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 23, 2021
• Study Start: January 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)