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What Counts as Evidence for a Rehabilitation Device, and Who Pays to Find Out
Over many years of working in rehabilitation, I've heard two questions from clinicians more often than any others. What's the evidence that this works and is safe? And what's the cost?
They're the right questions. A therapist who asks them is protecting a patient from misplaced hope and a budget from wasted money. What I've come to doubt is whether we all mean the same thing by the first one. "What's the evidence?" is usually asked as if evidence were a single ladder, with a large, blinded randomised trial at the top. If a device has no trial at the top, the conversation can end there.
For a rehabilitation device, that evidence ladder often doesn't fit, and the reasons are practical rather than philosophical. I've set them out at length in a new whitepaper, and this article is the short version: how device evidence gets graded, why so much of it lands at "low certainty", what that verdict does and does not mean, and how the money decides how much evidence ever gets produced.
The efficiency of FES Cycling
In this article, we look at the efficiency of FES Cycling and see that there is actually lots of room for improvement when it comes to metabolic efficiency and power output.
Of course that does not mean that they should not be used. Much research over decades shows the benefits for users from regular training. FES Cycling performance is good enough to produce results if people use these products. The benefits are greater than those via passive cycling alone.
However, any engineer who looks closely at the technology will realise that there is much that can be improved when it coms to FES cycling exercise. This is what engineering aims to do - refine and improve things for the benefit of society. Improving the technology could produce a greater health benefit for the same or less effort so it's worth striving for. It should also be said that this is no trivial challenge. All electro-mechanical systems that interact with the human body tend to offer design difficulties that are not obvious to the casual observer.