Procedures and cybernic treatment

After providing informed consent, eligible patients were enrolled into the pre-observation period of the trial (Fig. 1), during which the patients wore HAL-HN01 to ensure proper functioning of the CVC and shoe sensors and were subsequently randomised to group A or B.

Treatment 1 (conventional control treatment) consisted of a 40-min walking session using only a dedicated hoist (All in One®, Ropox A/S, Denmark) (Fig. 2A). The hoist was used for safety, to prevent falls, and to facilitate the provision of any gait assistance needed by the medical staff. A single walking session comprised warming up, 20 to 30 min of walking exercise depending on the patient’s condition, a brief rest, and a period of cooling down. Treatment 2 (cybernic treatment intervention) also consisted of a 40-min walking session using a hoist, with HAL-HN01 applied to the lower limbs (Fig. 2B). For both the treatments 1 and 2, the patients in groups A and B completed the sessions in nine visits (days), up to four visits per week, over a 13-week allowance period. The alternate treatment of either treatment 2 or 1 was then completed (Fig. 1). A transfer period, from one to 3 weeks, was scheduled between the treatments 1 and 2 to prevent any interference between the treatments’ efficacies and adverse effects. At the end of this period, there was a 4-week post-observation period to observe the persistence of clinical efficacy and the occurrence of adverse events after treatment. The treatment efficacy was evaluated as the change rate in the measured outcomes as follows: from the first to the final session of treatment 1 (i.e., Visit (V) 4 and V13 for group A and V14 and V23 for group B), and from the first to the final session of treatment 2 (i.e., V14 and V23 for group A, and V4 and V13 for group B), as well as to the final session of the post-observation period (i.e., V24 for both groups).

Photographs showing the use of mobile hoist and HAL-HN01 in control and cybernic treatments. A Control treatment (treatment 1), patient in hoist only. B Cybernic treatment (treatment 2), patient in hoist + wearing HAL