Pilot study to evaluate the effectiveness of a mobile-based therapy and educational app for children

With the new regulations on mobile medical applications (apps), the FDA has classified mobile apps that use games to motivate patients to perform health-related activities at home (such as physical therapy exercises) as a mobile medical application. Due to it posing lower risk to the public though, the FDA will only exercise enforcement discretion. The question is thus posed--when should apps that promote physical therapy at home for children with motor disabilities, apps in which the therapy is part of their overall rehabilitation protocol, transition to regulatory oversight? Of course this transition will not transpire until therapists begin to rely on data extracted from these apps and use this information to revise the therapy protocol for their patients. This leads to the first issue that should be addressing when dealing with the novel nature of mobile-based healthcare applications--validating the effectiveness of these types of apps. As such, in this paper, we present a pilot study to collect empirical evidence on the effect of a mobile-based healthcare application, designed for children, that is focused on improving motor skills. Results from the protocol, which involved eighty-five participants, show that these types of apps may result in a significant change in motor skills learning. Although the study in this paper involved adult participants, the methods proposed could be adapted by special education teachers and therapists to assess the quality of other such applications used by children in various educational and therapy settings.