Active not recruitingOBSERVATIONAL

A Novel Wearable Digital Biomarker for Detecting Changes in Multiple Sclerosis (MS) Condition

This study aims to test a new way of monitoring Multiple Sclerosis (MS) using special smart insoles in your shoes and a smartphone app. Many people with MS experience changes in how they walk, and these insoles can measure these changes from the comfort of your home. The goal is to see if this technology can effectively track how MS is affecting someone's day-to-day condition, particularly their walking ability. By collecting this information regularly, doctors hope to get a clearer picture of how MS is progressing, which could help them tailor treatment plans more precisely. It's about finding a more convenient and objective way to understand MS changes without needing constant clinic visits.

At a glance

Status

Active not recruiting

Sponsor

Celestra Health Systems

Enrolment target

Start

01 Jul 2023

Estimated completion

31 Dec 2026

Multiple Sclerosis

What is this study about?

Imagine being able to keep an eye on your Multiple Sclerosis (MS) symptoms, especially how you walk, from the comfort of your own home. That's exactly what this study is exploring! Researchers are testing a new system that uses smart insoles, which fit into your regular shoes, and a smartphone app. These insoles have tiny sensors that can measure details about your walking, like pressure and movement, almost like the advanced equipment used in a hospital walking lab.

Why focus on walking? For many people with MS, changes in how they walk are very common and can significantly impact their daily life. Doctors currently assess walking during clinic visits, but this can be time-consuming and doesn't always capture the subtle changes that happen day-to-day. This new technology could provide doctors with ongoing, detailed information about your walking patterns, helping them understand how your MS is progressing over time. This continuous monitoring might even help detect subtle changes that could indicate a shift in your condition earlier.

The information collected by the smart insoles is processed using clever computer programs, known as Artificial Intelligence (AI). This AI helps turn the raw sensor data into meaningful information about your walking. A small part of this information can also be shared with you through the smartphone app, helping you stay informed about your own progress and feel more involved in managing your condition. The aim is to give both you and your doctor a clearer, more objective picture of your MS journey.

Key takeaways

This study is testing smart insoles and an app to monitor MS from home.
It focuses on tracking changes in walking, a common MS symptom.
The goal is to provide doctors with more objective and frequent data about your MS.
You wear special insoles in your own shoes, no extra clinic visits or medication.
It uses clever computer programs (AI) to analyse your walking data.
It could lead to earlier detection of changes and more personalised treatment plans.

Who may be eligible?

To join this study, you need to have a diagnosis of Multiple Sclerosis (MS) and be between 18 and 60 years old. Your MS should also be at a certain level of severity, meaning your walking ability needs to be within a specific range according to a standard scale doctors use.

The researchers are particularly looking for a mix of participants, including some who experience specific walking challenges related to MS, such as problems with coordination, weakness on one side, or muscle stiffness. They also want to include people who have a progressive form of MS.

However, you can't join if you currently have a muscle or bone injury, like a sprain or a broken bone, that affects how you move your joints. You also need to be able to understand what the study involves and agree 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.

Do you have a diagnosis of Multiple Sclerosis (MS)?
Are you between 18 and 60 years old?
Is your MS severity within a certain range that allows you to walk?
Do you *not* currently have an injury (like a sprain or broken bone) that seriously affects your movement?
Are you able to understand and agree to take part in a study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't need to visit a clinic or take any new medication. Instead, you'll be given special smart insoles that fit into a pair of your everyday shoes. These insoles look and feel similar to comfortable insoles you might buy from a pharmacy. You'll wear these insoles as you go about your daily life, and they will quietly collect data about your walking several times a week. This data will then be sent to a smartphone app.

The study is focused on monitoring your condition from home, so there are no specific clinic appointments or additional medical assessments required beyond what your regular MS care involves. The total duration of your participation in the study is not specified, but it focuses on day-to-day monitoring using the insoles and app.

Potential risks and benefits

A potential benefit of joining this study is contributing to new technology that could lead to better ways of monitoring MS from home, potentially helping doctors tailor treatment plans more effectively in the future. You might also find it helpful to see some of your walking data through the app. As for risks, the smart insoles are designed to be comfortable and similar to regular insoles, so physical risks are expected to be very low. The main potential risk would be related to data privacy, though researchers take steps to protect your information. Remember, taking part in any study is entirely voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (3)

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

Brigham and Women's Hospital
Verified postcode
Boston, United States
The Ottawa Hospital
Verified postcode
Ottawa, Canada
The Royal London Hospital
Verified postcode
London, United Kingdom

Common questions

What are 'smart insoles'?

They are special insoles for your shoes that have small sensors built in. They look and feel like regular comfortable insoles but can measure information about how you walk.

Do I need to change my shoes for this study?

No, the smart insoles fit into a pair of your 'everyday use' shoes. You don't need special footwear.

Will I have to go to a clinic often?

No, this study is designed for you to wear the insoles at home. It aims to monitor your condition without frequent clinic visits.

What kind of information will the insoles collect?

They will collect data about your walking, like pressure and movement, to help understand changes in your MS condition.

Will I see my walking data?

Yes, a part of the walking information collected by the insoles will be shared with you through the smartphone app.