Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injury: a framework towards the standardisation of clinical evaluations.

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 Registration https://trialsearch.who.int/ , DRKS00023503, retrospectively registered on November 18, 2020.

Improving linking interface between collagen-based hydrogels and bone-like substrates.

Regenerative medicine requires the use of heterogeneous scaffolds when the tissue that needs to be repaired presents a gradient in its properties and cannot be replaced by a homogeneous graft. Then, an intimate contact between the different layers is critical to guarantee the optimal performance of the construct. This work presents a procedure that allows the immobilization of collagen-based hydrogels by self-assembly onto any desired substrate, by means of a pentafluorophenyl methacrylate (PFM) coating obtained by plasma enhanced chemical vapor deposition and a collagen monolayer. The latter is attached onto the PFM-coated substrate thanks to its high reactivity towards amines and it will act as anchoring point for the subsequent collagen fibrillation and hydrogel formation. The interaction between collagen and PFM-coated substrates has been evaluated using the quartz crystal microbalance with dissipation (QCM-D) technique. In addition, QCM-D has been used to design and monitor the collagen fibril formation process. A correlation between QCM-D data and optical microscopy has been established, and fibril formation has been confirmed by atomic force microscopy (AFM).