Feasibility and safety of training with an exoskeletal robotic device for Japanese individuals with spinal cord injuries: a retrospective study.

All the patients were treated at one rehabilitation centre, so the results may reflect that centre's equipment, staff and patient mix rather than what would happen elsewhere. The records were reviewed retrospectively, and the authors say selection bias should be considered because of this. There was no untreated comparison group, so the study cannot separate the effect of the device from months of supervised gait training, from the patients' own recovery, or from the fact that they were selected for the programme. Patients had to agree to weekly visits over several months to take part, so the group is likely to be more motivated than an unselected clinic population; the authors say motivation, functional ability and social participation may affect progress in the general population. The authors note that their cases may have been slightly less severe than those in previous studies. The authors suggest that some earlier reports may not have counted skin pressure problems as adverse events, so the comparison with past studies may be affected by how events were reported. The authors state that a multi-centre study is needed to establish a clearer picture of the feasibility of this training.

The data came from routine clinical practice and no additional funding was received. The authors declare no competing interests. The training programme itself was developed by ReWalk Robotics, the company that makes the device.

Do not read this as evidence that the exoskeleton restores walking. There was no comparison group, and eight of the 28 patients either dropped out or still needed moderate or greater assistance, so the results cannot separate the device from the months of supervised training or from the patients' own recovery. Do not assume the safety record is better than earlier reports, either: adverse events were more common here than in previous studies.