Actively Recruiting
Clinical Feasibility of the IMES Transradial Prosthesis
Led by Össur Iceland ehf · Updated on 2024-10-08
3
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of using implantable myoelectric sensors (IMES) to control a transradial prosthesis for people with unilateral transradial amputation. The study aims to assess how well these sensors can wirelessly transmit muscle signals from the residual forearm muscles to operate an electromechanical wrist and hand prosthesis. This device is being studied to improve prosthetic control and functionality. The study involves surgically implanting up to 16 IMES devices into the residual forearm muscles of three participants. After a two-week recovery period, participants will undergo a two-week training phase with their custom-fit IMES transradial prosthesis, including the electromechanical wrist and hand. Following training, the participants will use the prosthesis at home for approximately four months. They may also attend up to five follow-up visits after the study period. During the study, participants will be assessed at 11 time points, including baseline measurements with their own prosthesis and 10 visits with the investigational device over about six months. Researchers will evaluate grip accuracy as the primary outcome to measure device usability and functionality. The study includes ongoing monitoring and assessments to understand how well the implanted system works in daily life.
CONDITIONS
Brief Title
Clinical Feasibility of the IMES Transradial Prosthesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral acquired transradial amputation
- Residual limb size suitable to fit investigational device components
- At least 6 residual muscle locations available for implantation
- Good compliance with health service and rehabilitation
- Willingness to undergo surgical implantation of IMES sensor implants
- Experience with myoelectric upper limb prostheses
- Using own myoelectric device approximately 6 to 8 hours per day
- Ability to provide informed consent and attend study visits
You will not qualify if you...
- Any condition that poses a health risk according to the investigator
- Neurological disorder that may prevent accurate control of the prosthesis
- Major injury above the amputation level
- Neuromuscular disorder
- Nerve damage causing loss of muscle function planned for implantation
- Allergy to implanted materials
- Presence of an existing active implant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 weeks
Participants undergo surgical implantation of up to 16 Implantable Myoelectric Sensors (IMES) into residual forearm muscles and recover for approximately two weeks.
Duration - Approximately 4.5 months
Participants begin a two-week training phase followed by approximately four months of home use with their custom-fit IMES Transradial Prosthesis, including electromechanical wrist and hand.
Approximately 10 study visits during this period
Duration - Up to 5 visits after treatment
Participants are offered up to five post-study follow-up visits to evaluate the usability and functionality of the prosthetic system.
Up to 5 post-study follow-up visits
Trial Site Locations
Total: 1 location
1
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom, 0000 000
Actively Recruiting
Research Team
D
Daire McGuinness, BSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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