Efficacy of an exoskeleton-based physical therapy program for non-ambulatory patients during subacute stroke rehabilitation: a randomized controlled trial.

The trial was stopped early and included only 36 participants, which makes it harder to detect a real benefit. Five exoskeleton participants stopped using the device, and seven participants were lost to the 6-month assessment. Therapists could decide how much exoskeleton training to use and when to stop, so the dose varied widely. The exoskeleton group averaged 592 steps per session, which the authors note is low compared with other walking intervention studies. Cardiovascular intensity was not measured or targeted, which may have limited training effect. Only two therapy sessions per week were monitored, so the full amount of practice in each group is uncertain. The analysis did not account for hospital or baseline-balance stratification, or for repeated measures over time, because the sample was small. Only patients who could not walk independently were included, so it says little about patients who already walk with less assistance. The groups were not balanced for sex or stroke type, and non-ambulatory status is rated by an assessor and can be subjective.

Funding came from the Heart and Stroke Foundation of Canada and the Canadian Institutes of Health Research. The device manufacturer did not design, conduct or report the study.

Do not conclude that exoskeleton training improves walking after subacute stroke. The primary comparison was null, and the positive findings from analyses that grouped participants by the treatment they actually received were exploratory and were not confirmed when non-adherent participants were removed.