Article

Rehabilitation robots are increasingly being tested and promoted for clinical
neurorehabilitation. Compared with conventional and manual methods, robots allow
for a variety of advantages, particularly in the areas of interventional control
and the ability to provide a high volume of facilitated movement. Since 1997,
there have been more than 60 clinical trials reporting the use of two dozen
different robots for neurorehabilitation. Although there are a number of smaller
pilot studies, there are only few larger clinical trials. There may be a number
of reasons why pilot robot studies do not materialize into larger studies. Beyond
devices that failed to perform as intended, what are the clinical design issues
that have limited these studies? Some basic considerations include randomization,
inclusion of a control group, power calculation based on a clinically meaningful
outcome, and finally, reproducible descriptions of the intervention being tested.
Although many of these issues are general challenges presented for all
rehabilitation studies, there are clinical design features that would likely
greatly improve interpretation of results and better position robot devices
toward the next clinical trial step. On the other hand, the absence of these
elements, even in the setting of a pilot study, may significantly hamper the
interpretation of results and not yield sufficient information on treatment
effects, adverse event rates, dropout rate, and so on, to allow further testing
to proceed to follow-up Food and Drug Administration phase II and III studies.
Development of rehabilitation robots for clinical use needs to occur hand in hand
with well-conducted clinical trials to provide evidence of efficacy while also
taking into account costs.

Langue : ANGLAIS