Washington, DC-based modus health, a spin-off of a prosthesis company called Orthocare Innovations, has launched with the goal of creating a wearable activity tracker for clinical use. The technology is building on a research device called StepWatch that Orthocare has been using for some time.

"It’s sort of a wearable [that was created] before wearables were cool and it is a validated wearable that’s an FDA Class 2 device that has quite a following in the research world," Doug McCormack, president of modus, told MobiHealthNews. "And we felt very strongly that it would be an opportunity to get that core technology and translate what’s really been a research device into something that can have a meaningful impact on clinical care."

While the consumer activity tracker market continues to be one of the hottest spaces in digital health, the use of wearable trackers in actual clinical contexts is still fairly limited. The Mayo Clinic used the Fitbit in a high-profile study on cardiac rehabilitation patients, and PatientsLikeMe has recently begun using its network of patients to collect data from consumer trackers, but these examples are few and far between. 

Part of the reason is that devices like those from Fitbit and Jawbone aren't FDA cleared as medical devices, and haven't established their accuracy enough to be used in rehabilitation or physical therapy. In fact, one of the only fitness tracking devices that has FDA clearance is the BodyMedia CORE Armband.

Modus's StepWatch, which is worn around the ankle, was developed more than a decade ago for research purposes, to aid in the development of prostheses. Over the past 15 years, according to the company, it has been the subject of 200 peer-reviewed studies, a few of which directly compared it to devices like BodyMedia and found it to be more accurate. The device uses a proprietary mechanical sensing system rather than the tri-axis accelerometer common to nearly every commercial activity tracker.

While commercial wearable activity trackers might be sufficiently accurate to give the average person a good sense of their movement, people who need to track their movement in a clinical setting often move in ways that can fool a sensor. StepWatch is tested with people with prostheses or people with slow or irregular gait as a result of neurological conditions like stroke, Parkinson’s disease, multiple sclerosis and cerebral palsy. It has also been tested with COPD patients, who need physical rehabilitation as part of their treatment.

"In the areas where we’re able to track steps and to track activity in patient populations where other devices have not been effective at doing that, we feel there’s a tremendous opportunity," McCormack said. "It’s patients with neurological conditions, patients with disabilities, it’s seniors and it’s really people who are slow walkers. From our perspective that actually makes up some fairly significant segments of the patient population. We feel like we have a window into activity in this unique segment, that’s very important both clinically and from a payer standpoint."

At the moment, one of the biggest hurdles for StepWatch is that it has no wireless connectivity. Users have to have a special docking station or bring the device into a clinic. But McCormack is confident that the mobile piece can be added without too much trouble. The company is currently working on modifying the device to upload data to a mobile device via Bluetooth.