Stroke is a major cause of disability and death among adults in the U.S. It is estimated that 2/3 of people who suffer a stroke do not regain full physical function. When the upper body is affected, patients can have difficulty performing activities of daily living such as dressing, bathing and self-care. This story covers a novel rehabilitation device called the Tailwind. This simple mechanical device allows a patient to use exercise both arms independently, instead of just the affected arm. However, this story seems a bit like a marketing strategy for an entrepreneur who is selling the Tailwind. It features a patient who has had great success with rehabilitation. It does not provide any detailed information about the evidence supporting the physical benefits. The story fails to indicate the Tailwind was developed based on two small, short-term studies. These studies showed rehabilitation with a prototype of the Tailwind device can improve movement-related activation in some areas of the brain and arm function in some cases. These improvements are significant because they occurred in stroke survivors years after further recovery was anticipated. Thus, this type of rehabilitation device has potential to improve upper body function for chronic stroke patients. But, the story also fails to mention that about 1/3 of patients using the device had no improvement. Overall this story highlights an interesting and potentially important advance in stroke rehabilitation. What it lacks is balance in providing evidence to support the commercial sale of the Tailwind.
This story states that the Tailwind device costs $2,400. (The actual price is $2,495 + shipping.) The stroke patient featured in the story was given this device for free. At the time the article went to press, no Tailwind devices have been sold.
This article provides some information on benefits including increased activation of some areas of the brain when the affected arm moves and improvement in function that allows patients to have better use of the affected arm. However, without citing specific scientific evidence, the reader cannot determine whether these results are typical or whether this patient featured is the exception. We are given a case study of a single patient who goes from a "useless limb" to "…play catch with his grandson and hit a golf ball nearly 100 feet." We have no idea if this is a representative effect or an outlier. There are no quantitative data given about benefits.
No harms were noted in the story. While the potential for adverse effects seems limited, 2 studies involving a total of 35 patients is inadequate to address this issue. In addition, in the small studies, patients were carefully monitored.
This story presents very little scientific evidence other than referencing to studies published in Stroke (2000) and the Journal of the American Medical Association (2004). These studies were conducted in chronic stroke patients with severe weakness and partial paralysis in their upper body. What the article should have mentioned is that the initial pilot study had 14 patients and was not a randomized controlled trial (RCT). This pilot study showed improvement in movement of the affected arm and patient satisfaction. The follow-up study was a small RCT conducted in a total of 21 patients about 3 years after they had a stroke. Patients using the prototype Tailwind device showed increased activity in some areas of the brain. About 2/3 of these patients had functional improvements while 1/3 had no improvement.
The story notes the incidence of stroke and that strokes are a leading cause of adult disabilities. The story could have been improved by telling readers how many of the 750,000 with stroke have important functional disabilities at 3 or 6 months post-stroke.
A variety of people were interviewed for this story. Information was presented by researchers who developed and tested the device, a chronic stroke patient who has had positive results from rehabilitation, and an indepent medical expert. It wasn’t a very balanced group of interviewees, but at least some attempt was made to consult an independent expert.
Only high tech options seemed to get any mention – such as robot-assisted movement, electrical impulses to the brain and specialized treadmills.. But there was no mention of standard stroke rehab programs. There is no mention of "stroke units" used during the acute phase.
The story made it clear that "Formal marketing begins in the next few weeks, and none have sold yet." However, the hefty price tag and the fact that this device is not covered by Medicare will likely limit availability. (See Cost and Benefits comments.)
The Tailwind device does offer a new approach to stroke rehabilitation.
This article does not appear to rely on a press release.