Clinical Trial Summary
Stroke is reported as one of leading causes of adult disability. Recent advances in in
revascularization therapy have had a significant impact on clinical and functional outcomes
in patients with ischemic stroke. However, revascularization therapy can only be applied to a
limited population of patients. Many stroke survivors are still suffering from significant
motor impairments and gait disturbance. The recovery of the ambulatory function in stroke
patients is one of the most important goals of their rehabilitation and a critical factor
influencing the patient's home and social activities.
One of the most frequently occurring disabilities in stroke patients is the ambulatory
impairment. Ambulation is a key factor in performing the activities of daily living. About
80% of stroke patients showed the ambulatory impairment in acute stroke phase, and many
stroke patients were not fully regain the ambulatory function although the ambulatory
function was rapidly restored within 6 months after onset. Because the ambulatory function is
the most important relating factor on activities of daily living and quality of life, one of
the most important goals of stroke rehabilitation can be the achievement of independent gait.
The conventional gait rehabilitation has been performed as a 1:1 training session between the
therapist and a stroke patient. This gait rehabilitation can make a significant burden on the
therapist and restriction of the rehabilitation time. The limited number of rehabilitation
facilities and therapists for the number of stroke patients requiring rehabilitation means
that many stroke patients might receive not enough gait rehabilitation.
To overcome these issues, a lot of studies have been conducted to develop rehabilitation
robots for effective gait training. Nonetheless, in previous studies regarding robot-assisted
gait rehabilitation, the stroke patients varied in terms of their baseline gait ability,
functional level, and onset of stroke. In addition, robots for gait rehabilitation robots
were various such as exoskeletal, end effector and overground gait types with varied
frequency, duration and intensity of the gait rehabilitation training. Such heterogeneity
inevitably limited the quality of the studies as well as the application in clinical
practice. For an adequate robot-assisted gait rehabilitation in clinical practice, the
functional level and the phase of stroke patients should be taken into consideration. In
addition, for the gait rehabilitation robots to be applied effectively, it also should be
considered to have a defined indication as well as a protocol including frequency, duration
and intensity of robot-assisted gait rehabilitation.
A robot could have efficiency in assisting patients to practice correct and repetitive
movements with the adequate quantity and intensity of training. The robot-assisted gait
rehabilitation using a treadmill-based robot for location control has increased in stroke
rehabilitation. However, the conditions of treadmill gait differ from those of actual
overground gait so that the increase in gait ability after treadmill-based training might not
directly translate into the improvement of overground gait. In addition, a drawback of such
gait training using a robot for location control could be the difficulty in adapting the
robotic movements to the patient's efforts to move the muscles and to the passive
characteristics of the musculoskeletal system. On the contrary, overground gait training has
been reported to improve the gait speed and endurance to a greater degree than treadmill gait
training in stroke patients.
Recently, overground gait training using an exoskeletal wearable robot has been proposed to
promote the activation of the nervous system by inducing an active participation from the
patient who performed active balance control, weight shift, and muscle activation. In the
previous study, the effect of gait training using an exoskeletal robot was reported in
patients with incomplete paraplegia caused by spinal cord injury. Nevertheless, lack of
studies have reported on the effect of gait training using an exoskeletal wearable robot in
subacute stroke patients.