JMIR Publications

ABSTRACT

Background:

Gait disturbance often occurs in stroke survivors. Recovery of walking function is challenging, as some gait disturbance due to hemiparesis often remains even after rehabilitation therapy, representing a major obstacle towards regaining activities-of-daily-living performance and achieving social reintegration.

Objective:

This study aims to clarify the effectiveness and safety of a walking program involving the wearable Hybrid Assistive Limb (HAL-TS01) robotic exoskeleton for improving walking ability in stroke patients with hemiparesis and stagnant recovery despite ongoing rehabilitation.

Methods:

This is a multicenter, randomized, parallel-group, controlled study (HAL group, n=27; control group, n=27). The study period includes pre-intervention observation (until stagnant recovery), intervention (HAL-based walking therapy or conventional rehabilitation; 5 weeks), and post-intervention observation (2 weeks). Following provision of informed consent and primary registration, the patients undergo conventional rehabilitation for pre-intervention observation, during which the recovery of walking ability is monitored to identify patients with stagnant recovery (based on weekly tests assessing the 10-m maximum walking speed, MWS). Patients with MWS of 30–60 m/min and insufficient weekly improvement in MWS undergo secondary registration and are randomly assigned to undergo HAL-based walking therapy (HAL group) or conventional rehabilitation (control group). The primary endpoint is the change in MWS from baseline to the end of the 5-week intervention.

Results:

This study began in November 2016 and is being conducted at 15 participating facilities in Japan.

Conclusions:

Assessments of walking ability vary greatly, and it is difficult to define the threshold for significant differences. To reduce such variability, our study involves conducting conventional rehabilitation to the point of saturation before starting the intervention. Stagnation in the recovery of walking ability despite conventional rehabilitation highlights the limits of current medical care. The present study may bring evidence that HAL-based therapy can overcome such limitations and induce additional recovery of walking ability, which would promote the use of HAL technology in the clinical setting. Clinical Trial: This study has been registered with the University Hospital Medical Information Network (UMIN trial registration number: UMIN000024805).