RecruitingNAINTERVENTIONAL

Clinical Feasibility of the IMES Transradial Prosthesis

This study is testing a new way for people with an amputation below the elbow to control their artificial hand. It's called the IMES Transradial Prosthesis. Small sensors are placed inside the remaining arm muscles. These sensors wirelessly send signals from your muscles to the artificial hand and wrist, allowing you to move it more precisely. The main aim is to see how well this new technology works and how easy it is for people to use in their daily lives. After a short recovery and some training, people will get to use the new hand at home for about four months. Researchers will regularly check how they are getting on to make sure it's helpful and comfortable.

At a glance

Status

Recruiting

Phase

Sponsor

Össur Iceland ehf

Enrolment target

Start

01 Jan 2023

Estimated completion

01 Jan 2026

Amputation

What is this study about?

This research is looking into a new kind of artificial hand and wrist for people who have had an amputation below the elbow. It's called the IMES Transradial Prosthesis. The main idea behind it is to make controlling an artificial hand feel more natural and intuitive, almost like moving your own hand.

Currently, many artificial hands use signals from muscles, but this new system involves placing very small sensors directly into the muscles that are left in your forearm. These tiny sensors can pick up electrical signals from your muscles and wirelessly send them to the artificial hand. This allows you to control the wrist and hand movements with your thoughts and muscle intentions, making it potentially easier and more effective than current options.

The study wants to find out if this new system is easy to use and if it works well for everyday activities. They will also check if the sensors are safe and comfortable once they are inside the body. If successful, this technology could offer a real improvement in how people use and interact with their artificial limbs, giving them more independence.

Key takeaways

New artificial hand with muscle-controlled sensors.
Requires a small operation to implant sensors.
Potential for more natural and precise hand control.
Study involves recovery, training, and 4 months of home use.
Regular checks by the research team.
You can leave the study at any time.

Who may be eligible?

To join this study, you would need to be an adult between 18 and 65 years old who has had an amputation below the elbow affecting only one arm. Your remaining arm would need to be of a size that fits the special parts of this new artificial hand. You should also have enough healthy muscle locations in your forearm where the small sensors can be safely placed.

It's important that you usually follow medical advice well and are willing and able to have a small operation to put the sensors in. You should also already be experienced in using artificial hands that are controlled by muscle signals and typically use your current artificial limb for about 6-8 hours each day. You need to be able to understand what the study involves and be able to come to all the appointments.

However, you wouldn't be able to join if you have certain health conditions like a nerve problem that could affect your ability to control the hand, or if you have any major injuries above your amputation. Allergies to materials used in medical implants would also exclude you, as would already having another active medical implant in that area, or any other health issue that the study doctors feel would make it unsafe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Do you have an amputation below the elbow on one arm only?
Do you already use an artificial hand that's controlled by muscle signals?
Are you able to have a small operation to put sensors in your arm?
Do you typically follow medical advice well?
Are you able to attend study appointments regularly?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have a small operation to place up to 16 tiny sensors into the muscles in your remaining forearm. After this surgery, you'd need about two weeks to recover. Then, you'd start a two-week training programme to learn how to use these sensors to control the new artificial hand. Once you have learned how to use it, you will receive your custom-made IMES Transradial Prosthesis, which includes the special wrist and hand.

You would then use this new artificial hand at home for around four months as part of your daily life. Throughout this time, the research team will regularly check in with you to see how you are getting on and how well the system is working. There will be initial visits to fit and train you, and then regular checks during the home use period. After the study finishes, you might be offered up to five extra follow-up visits to continue checking your progress. The total duration of active participation (from surgery to the end of home use) would be about 4.5 to 5 months, plus any optional follow-up visits.

Potential risks and benefits

Taking part in this study could offer you the benefit of trying a new advanced artificial hand that might give you more natural and precise control than current options, potentially improving your daily independence. However, like any medical procedure, there are potential risks, mainly from the surgery to implant the sensors, such as infection or discomfort. There's also the chance that the system might not work as well for you as hoped. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

NHS Greater Glasgow and Clyde
Verified postcode
Glasgow, United Kingdom· Recruiting

Common questions

What is an IMES Transradial Prosthesis?

It's a new type of artificial hand and wrist for people with an arm amputation below the elbow, controlled by small sensors placed in your arm muscles.

Will I need surgery?

Yes, you would need a small operation to place the tiny sensors into the muscles of your forearm.

How long will I be using the new hand?

After recovery and training, you would use the new hand at home for about four months.

What happens after the study ends?

You may be offered up to five extra visits to check on your progress and how you are getting on with the prosthesis.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your medical care.

How to find out more

Daire McGuinness, BSc

dmcguinness@ossur.com 00441315070097 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.