Background Robotic lower-limb exoskeletons have the potential to provide additional clinical benefits for persons with spinal cord injury (SCI). However, high variability between protocols does not allow the comparison of study results on safety and feasibility between different exoskeletons. We therefore incorporated key aspects from previous studies into our study protocol and accordingly conducted a multicentre study investigating the safety, feasibility and usability of the ABLE Exoskeleton in clinical settings. Methods In this prospective pretest-posttest quasi-experimental study across two SCI centres in Germany and Spain, in- and outpatients with SCI were recruited into a 12-session training and assessment protocol, utilising the ABLE Exoskeleton. A follow-up visit after 4 weeks was included to assess after-training outcomes. Safety outcomes (device-related adverse events (AEs), number of drop-outs), feasibility and usability measures (level of assistance, donning/doffing-time) were recorded at every session together with changes in gait parameters and function. Patient-reported outcome measures including the rate of perceived exertion (RPE) and the psychosocial impact of the device were performed. Satisfaction with the device was evaluated in both participants and therapists. Results All 24 participants (45 ± 12 years), with mainly subacute SCI (< 1 year after injury) from C5 to L3, (ASIA Impairment Scale A to D) completed the follow-up. In 242 training sessions, 8 device-related AEs (pain and skin lesions) were reported. Total time for don and doff was 6:50 ± 2:50 min. Improvements in level of assistance and gait parameters (time, steps, distance and speed, p < 0.05) were observed in all participants. Walking function and RPE improved in participants able to complete walking tests with (n = 9) and without (n = 6) the device at study start (p < 0.05). A positive psychosocial impact of the exoskeleton was reported and the satisfaction with the device was good, with best ratings in safety (participants), weight (therapists), durability and dimensions (both). Conclusions Our study results prove the feasibility of safe gait training with the ABLE Exoskeleton in hospital settings for persons with SCI, with improved clinical outcomes after training. Our study protocol allowed for consistent comparison of the results with other exoskeleton trials and can serve as a future framework towards the standardisation of early clinical evaluations. Trial Registrationhttps://trialsearch.who.int/, DRKS00023503, retrospectively registered on November 18, 2020.

Background Telemedical services can be used to complement on‐site services when demand for specialists exceeds supply or when specialists are not evenly distributed across health systems. Using stroke as an example, this study aimed to explore how patients and staff experience telestroke cooperation in a stroke network in Germany. Methods We conducted a qualitative multi‐method and multi‐centre study combining 32 non‐participant observations at one hub and four spoke hospitals with 26 semi‐structured interviews with hub and spoke staff as well as stroke patients and relatives. Observation protocols and interview transcripts were analysed to identify barriers and facilitators to telestroke cooperation from the perspectives of staff, patients and relatives. Results In terms of barriers to telestroke cooperation, we found technological problems, providing the treatment for one patient from two sites, competing priorities between telestroke and in‐house duties in the spoke hospitals, as well as difficulties in participating in the teleneurological examination via a videoconferencing system for older and disabled patients. In terms of facilitators, we found an overall very positive perception of telestroke provision by patients, good professional relationships within the network, and sharing of neurological expertise to be experienced as helpful for telestroke cooperation. Conclusions We recommend better integration of telemedical services into the care pathway, fostering relationships within the network, improved technological support and resources, and more emphasis within networks, in public awareness efforts as well as in academia on the evaluation of telemedical services from the perspectives of patients and relatives, especially older patients and patients with disabilities.

Zusammenfassung Hintergrund In Schlaganfallnetzwerken verlegen Kliniken, die selbst keine endovaskuläre Thrombektomie (EVT) durchführen (hier: Primärkliniken), Patient*innen für diese Therapie in spezialisierte Schlaganfallzentren. Zur Verbesserung des Zugangs und des Managements der EVT muss der Fokus der Forschung nicht nur auf den spezialisierten Zentren, sondern auch auf den vorangehenden Prozessen in den Primärkliniken liegen. Fragestellung Wie stellen sich die Schlaganfallbehandlungspfade in verschiedenen Primärkliniken dar und was wird in diesen Pfaden als Vor- und Nachteil gesehen? Methoden Im Rahmen einer qualitativen multizentrischen Studie in drei Primärkliniken eines Schlaganfallnetzwerkes wurde die Versorgung von Schlaganfallpatient*innen mithilfe von nichtteilnehmenden Beobachtungen und 15 leitfadengestützten Interviews mit Beschäftigten unterschiedlicher Professionen erfasst und analysiert. Ergebnisse Innerhalb der Schlaganfallbehandlungspfade wurden folgende Aspekte als vorteilhaft berichtet: (1) eine strukturierte und persönliche Ankündigung von Schlaganfallpatient*innen in der Primärklinik durch den Rettungsdienst, (2) ein effizienter Ablauf des Telekonsils, (3) die Notfallverlegung zur EVT durch die gleichen Rettungsdienstmitarbeitenden der Primärzuweisung und (4) die Integration von externen Neurolog*innen in klinikinterne Strukturen. Diskussion Die Studie liefert einen Einblick in die z. T. unterschiedlichen Schlaganfallbehandlungspfade drei verschiedener Primärkliniken eines Schlaganfallnetzwerkes. Aus den Ergebnissen lassen sich Verbesserungspotenziale auch für andere Kliniken ableiten. Allerdings ist diese Studie zu klein, um verlässliche Aussagen über deren Wirksamkeit zu geben. Zukünftige Studien sollten daher untersuchen, ob Implementierungen der hier erarbeiteten Empfehlungen tatsächlich zu Verbesserungen führen bzw. unter welchen Bedingungen diese erfolgreich sind. Zur Sicherstellung der Patientenzentrierung sollte dabei auch die Perspektive von Betroffenen und Angehörigen miteinbezogen werden.