Can you spare 30 minutes to answer a survey about a wearable device (ActiMyo) to measure muscle movements in Clinical Trials?

Do you have 30 minutes spare to help with a new survey?

Calling all patients, parents and carers of children and adults with myotubular and centronuclear myopathy. You are invited to help to complete a survey* about your opinions, expectations and concerns regarding the use of a wearable device (Actimyo, pictured) to measure movement digitally in clinical trials. The ActiMyo does not detect a patient’s GPS movements, but could help to demonstrate physical improvement in patient studies – ie, whether a drug is helping to improve muscle power, strength and function on a day-to-day basis. Please continue to read on for the formal invitation and Q&A’s before deciding to complete the survey. *The survey has been developed by Parent Project Muscular Dystrophy (PPMD) and Sysnav.

Thank you for considering participating in this important study.

Further information from the survey team

Hello Patients, Families and Carers

Wearable device and clinical outcome measures in real-life setting from the patients, families, and caregivers’ perspectives: An international cross-sectional survey on patients presenting with a neuromuscular disease.

You are invited to participate in a research survey for patients living with a neuromuscular disease, their families, and caregivers. This is an international survey developed by Parent Project Muscular Dystrophy (PPMD) and Sysnav to seek your opinion, your expectations, and your concerns regarding the use of a wearable device in clinical trials as well as the clinical meaningfulness of potential outputs.

Why this survey?

Sysnav is a company developing a wearable device for clinical trials (called ActiMyo®) in collaboration with clinicians, patients’ associations, and other parties, with the goal of accurately measuring clinically meaningful variables to assess the efficacy of new drugs in neuromuscular diseases. ActiMyo® is composed of sensors worn on the wrist and/or on the ankle(s) aiming to capture movements of arm and/or leg. ActiMyo® has no GPS tracking function and could not detect where the patient is.

Digital clinical outcomes are still in their infancy. Your voice is central to ensure that the outcome qualified are relevant for the patients and match the needs from the community.

In addition, regulatory agencies such as the FDA or EMA, rely on the input of patients and families to inform treatment approval decisions.

How is my information treated & analysed?

Data will be completely anonymous. Data will be collected, analysed, and used by Sysnav. Data will be stored as long as required for regulatory purposes (and at least 15 years). Collected data will be shared with any regulatory authorities who may review applications for device or clinical outcome measures approbation.

How do I participate?

This research survey is online and will take 20-30 minutes. You will not be paid for completing the survey. It is your choice to complete the survey. You can stop the survey at any time. By answering the survey, you consent that your data could be used for development of new digital endpoints and regulatory qualification.

Here is the link dedicated to patients living with a neuromuscular disease: