Study of Dynamic Arm Support in people with Duchenne

Use of a Powered Arm Support Device for Upper Limb Function in Non-Ambulatory Men with Duchenne Muscular Dystrophy (DMD)

Questions and Answers

What stage is this research?

This trial is actively recruiting participants who are age 14 or older, using a wheelchair for mobility, and experiencing arm weakness and limitations in activities of daily living. We plan to recruit 30 participants for this study.

Who is funding this study?

This study is funded by the Foundation to Eradicate Duchenne and conducted by the University of Pittsburgh, PI Dr. Roxanna Bendixen.

Who is eligible to participate in this study?

To participate in this study, you must be 14 years old or older, use a wheelchair for mobility, and have arm weakness that limits independence in performing daily tasks.

What do I have to do if I decide to participate in this study?

If you decide to participate in this study, you will be randomly assigned to use one of the two dynamic arm supports being evaluated to use during a four-week home trial: the JAECO WREX or the Kinova O540. During this device trial period, you will be asked to create goals for the use of the device, and to record the amount of time spent on your goals weekly. This information will help us understand the strengths and weaknesses of each dynamic arm support. Additionally, we are collecting information about how the devices work through a wrist worn activity monitor called an ActiGraph. We ask participants to wear this for two weeks prior to starting the device trial, throughout the device trial, and two weeks after. If, at the end of the device trial, you would like to trial the other arm support, you can choose to do a second four-week device trial. This is optional. All arm supports and the ActiGraph will be returned to the research team at the end of the study.

Other things to know are that you will not have to travel for any part of this study. The study team will come to your house, or an agreed upon location near you, for the installation and removal sessions. During these sessions, there will be testing items that we will complete with you. Each in-home session takes about 2 hours.

How long will this study last, and will I have access to the arm device once the study has ended?

The anticipated length of the study is 8 weeks, with an additional 5 weeks if you decide to trial the second device (called the cross-over device). The arm supports will be returned to the study team at the end of the trials, but we can help by connecting you to the vendors of either device if you are interested in buying an arm device after the trial.

Where does this study take place?

This study takes place in the comfort of your home and community. We will travel to you to install the devices and you will be able to use them within your community for the device trial period.

How many home visits are necessary?

At minimum there will be 2 home visits, one for the installation and one for the removal. If you choose to do the cross-over device trial, there will be an additional home visit.

Will I get paid for participating in this study?

Yes, after your completion of the device trial you will receive $100 in compensation for your time. If you decide to complete the cross-over device trial, you will receive an additional $50 after all of the study materials have been returned to the study team.

Why should I consider participating in this study?

While there is no direct benefit from participating in this research study, you will be contributing to the general knowledge base about what is known about the use of dynamic arm supports for young men with Duchenne. You will also be able to trial up to two dynamic arm support devices in your home environment to see if they are beneficial for you.

Where can I learn more about this study?

You can learn more about this study at www.ClinicalTrials.gov (NCT03531788)

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