Spinal cord atrophy (SMA) affects one in every 1,000 live births in Spain. Cerebral palsy (CP) is the most common cause of chronic motor disability in children, affecting two to three in every 1,000 live births. The Atlas 2030 exoskeleton is the first portable robotic pediatric exoskeleton aimed at facilitating walking in these children. It is used as a complement to other therapies.

We aimed to compare the efficacy and safety of the ATLAS 2030 exoskeleton with conventional physiotherapy in children aged between four and 12 years with SMA or CP. We conducted a literature search to identify clinical trials and systematic reviews in the PubMed, Embase, Web of Science, and Cochrane Library databases, finding 201 original articles published between 2017 and 2022. No controlled studies were found on the ATLAS 2030 or any other portable device, even after expanding the searches to any robot-assisted gait devices.

Although systematic reviews evaluating the efficacy and safety of robotic orthoses in general were found, there were no specific controlled studies on the ATLAS 2030. The five studies found (two on CP and three on SMA) were of low quality and did not show conclusive results in terms of efficacy and safety. However, some of them suggested that this technology could provide significant improvements in acceptability, range of motion, and spasticity. With respect to safety there appeared to be no evidence of serious adverse effects from its use, reinforcing the developer’s initial hypothesis that the technology is safe.

Although the available evidence is very limited, the ATLAS 2030 appears to show efficacy in some gait-related outcomes without serious adverse effects. To demonstrate safety and efficacy, randomized controlled trials are required that compare the ATLAS 2030 with conventional physiotherapy, with more participants and a longer duration, and are conducted by independent expert groups without conflicts of interest.

The RedETS horizon scanning (HS) program in Spain is focused on identifying non-pharmaceutical emerging health technologies. HS is organized in three steps: (i) identification using different sources (PubMed, the biomedical press, and others); (ii) screening performed by the HS Working Group and clinicians; and (iii) prioritization using the PriTec tool. This study aimed to evaluate the accuracy of RedETS HS in identifying disruptive emerging technologies for our health system.

Data from brief files and full reports related to the identified emerging technologies were collected. Full health technology assessment (HTA) reports were also reviewed. The period of analysis was from 2016 to 2023. The information collected included the name, type, category, and indication of the emerging technology and the source of identification. An ad hoc Excel spreadsheet was designed to collect the information. The analysis consisted of a description of the variables and an assessment of concordance between the emerging technologies identified and those with full HTA reports.

There were 338 emerging technologies identified. These technologies were mainly therapeutic (52.1%) or diagnostic (25.7%). In addition, about 45 percent were medical devices and 15.7 percent were in vitro diagnostic tests; imaging comprised 7.4 percent. Most of the emerging technologies were identified through the biomedical press (22.2%), PubMed (23.6%) and industry (20.3%). In a preliminary analysis of these main sources, 31 percent of the technologies identified by HS had full HTA reports, with all of these being identified three years before the HTA.

HS systems might help identify the most relevant technologies for healthcare systems, enabling them to be more ready to incorporate the new technologies. Therefore, HS must be able to detect emerging technologies that will have an impact on the health system. Periodic evaluation of the accuracy of HS programs will improve their impact in the HTA process.