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When developing a movement disorder monitor it is especially important to consider the desired end user. Even the most advanced movement disorder device would be worthless if the user was either unsure or unable to operate it. This is something CleveMed focused on when developing Kinesia HomeView (a take-home PD symptom monitor to help clinicians observe patients’ symptom patterns over a period of time). Movement disorders involve symptoms that are challenging to design considerations. By bringing PD patients who experience these symptoms into the office to interact with Kinesia HomeView, important feedback about the system’s mechanical and software design was gained. Design features that could have been burdensome to the end user were addressed and changed as necessary. In this article I would like to mention some of the features that were refined as a result of the user-feedback:

Mouse replaced with Touch-screen:

Using a computer mouse to record diary information wasn’t always feasible for focus group participants who experienced tremor, so the mouse was replaced with a touch-screen computer. This allows the user to hit a large target on the screen as opposed to worrying about the fine-tuned control required to navigate a mouse.

Motion sensor simplified for easier application:

In order for the system to be effective, a motion sensor needs to be placed on the hand by the PD patient. In its preliminary design, the sensor unit for HomeView was rather bulky, and some participants who were experiencing tremor found it cumbersome to strap it on both wrist and hand as required. After feedback the sensor was condensed into a single compact housing attached to the index finger. This new design can be slid directly over the finger.

Patient-friendly docking station for charger:

Finally, charging of the finger sensor battery was changed from a USB cable to a docking station. The docking station allows the end user to connect the sensor using a much larger target than a USB cable provides.

If CleveMed had not consulted with Parkinson’s disease patients about the design of Kinesia HomeView, the end product would have been far from ideal for home use. Getting user feedback is important throughout the development process of new medical devices like Kinesia HomeView. Engineers who don’t have the same life experience as the desired end user, will be unable to consider every aspect that could challenge the proper use of a device. The more a company incorporates the end user in the product development process, the more successful their end product will be.

Parkinson’s disease (PD) is a degenerative disorder of the central nervous system. The signs of Parkinson’s disease can be classified into three main categories: primary motor symptoms, secondary motor symptoms, and non-motor symptoms. Since Parkinson’s disease symptoms can range from motor to cognitive, coping with Parkinson’s disease can be very challenging.

Primary Motor Symptoms:

The primary Parkinson’s disease motor symptoms include resting tremor, bradykinesia (slowed movements), rigidity, and postural instability.

• Resting Tremor, the most common primary motor symptom of PD affects approximately 70% of people with Parkinson’s disease.¹ Tremor can affect the hand, foot, one side of the body, the jaw, and even the face. Since PD’s tremor is characterized mostly by resting tremor, the tremor occurs when the affected body part is not doing work and it usually subsides when the individual begins an action. Severe tremor can impair a person’s ability to perform everyday tasks, such as eating and getting dressed. (View video)
• Bradykinesia is characterized by slowed movements and incomplete movements. Furthermore, individuals who experience bradykinesia may have difficulty initiating movements, as well as sudden stopping of an ongoing movement, often called “freezing”.¹ Bradykinesia can significantly affect tasks such as walking.
• Rigidity is characterized by stiffness and inflexibility of the muscles.
• Postural Instability is characterized by impaired balance and coordination.

It is clear that the presence of one or more of the primary PD motor symptoms can be extremely detrimental to an individual’s quality of life.

Secondary Motor Symptoms:

The secondary Parkinson’s disease motor symptoms include symptoms such as stooped posture, fatigue, speech problems, and loss of facial expressions. Some individuals affected by PD may also experience drooling, difficulty swallowing, and sexual dysfunction.

Non-motor Symptoms:

Furthermore, there are non-motor symptoms of PD, which include confusion, sleep disturbances, constipation, skin problems, depression, anxiety, slowed thinking, urinary problems, fatigue, loss of energy, and compulsive behavior.

As I mentioned before, because Parkinson’s disease symptoms can range from motor to cognitive, coping with Parkinson’s disease can be very challenging.Currently, relatively little is known about the disease, and many research groups are attempting to determine both the cause and source of PD. Studying the symptoms with appropriate tools (like wireless accelerometers) can give clinicians and researchers clues into the underlying mechanisms that cause them.

CleveMed continues to design and build medical devices to monitor and measure Parkinson’s disease symptoms.

As many patients and clinicians are aware, Parkinson’s disease symptom fluctuation is a challenging part of the disease. The process of finding the correct balance of medication doses and appropriate administration times can be lengthy and frustrating to patients and their families. A single in-clinic exam does not accurately portray what a patient experiences at home and diaries and verbal communication may not always be the most reliable method of conveying that information.

Allowing patients to provide objective information on their experiences at home gives the clinician crucial information that may help adjust medication timing and dosage. This can increase the medication “on” times and give patients the ability to perform activities that are important to them more often.

CleveMed has developed Kinesia HomeView, a system for monitoring patient symptoms at home. A small motion sensor is worn on the patient’s finger while several times a day tasks for evaluating symptoms are completed, similar to those performed in the doctor’s office. An electronic diary is also available to allow patients to rate their symptoms and activities over the course of a day and also indicate when medications were taken. After Kinesia HomeView is used for one or more days, the clinician receives a web-based report which includes clinically validated 0 to 4 severity scores and patient diary information. This report provides information on how patient symptoms are fluctuating during the day in response to prescribed treatments. Using this detailed information, clinicians may be able to better minimize motor symptoms during the day by adjusting therapies such as medication times and doses or deep brain stimulation settings.

An informative video is available at www.clevemed.com/PD/IntroVideo.shtml that describes patient and clinician opinions on why home monitoring is an important part of Parkinson’s disease care.

If you are interested in learning more about Kinesia HomeView, please visit www.CleveMed.com/PD. Here you can find information for clinicians including reimbursement, validation studies and publications and the ability to test drive the web-based clinician interface. Information is also available for patients including an overview of Parkinson’s disease, information on the Kinesia HomeView system and an application to test drive the patient interface portion of the system.

Hello! My name is Danielle Madere, a recent graduate from Illinois Institute of Technology with a bachelor’s degree in biomedical engineering. In the past month, I was lucky to join the CleveMed family as their newest biomedical engineer.

My first two weeks on the job consisted of gaining familiarity with some of our devices: Kinesia, KinetiSense, and the BioRadio. There was also much training, many meetings, and assisting with grant writing.

In the coming months, I will be focusing a lot of my time on clinical studies for several movement disorder monitoring products that we are currently focusing on, specifically ETSense, ParkinStep, and PDRemote. I will be organizing meetings with patients, collecting symptom data, and performing some preliminary analysis to ensure the data we are collecting is valid.

I am very excited to work with CleveMed’s Movement team because I truly believe that our devices, such as Kinesia HomeView, will revolutionize the way clinicians treat movement disorders such as Parkinson’s disease. Presently, Parkinson’s disease symptoms are rated by the clinician, based solely on the clinician’s subjective opinion of the severity (UPDRS). Additionally, clinicians only see the patient for a very limited window of time in their office, which does not provide significant insight into the symptoms a patient faces at home, where treatment really matters. Kinesia HomeView will allow clinicians to observe the quality of life of a patient throughout the course of a day in the comfort of their own home, and adjust medication doses and frequency accordingly.

The more closely I interact with Parkinson’s disease and essential tremor patients, the more desperately I want to help improve their quality of life, and CleveMed gives me that opportunity, which I am eternally grateful for.