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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-assisted Training Group | Experimental | - After the baseline test, the training is performed with 20 sessions in total (60 min / session); five sessions a week for four weeks. The robot-assisted training group is given 30 min conventional gait training and another 30 min (excluding robot attachment and detachment time) gait training using an exoskeletal wearable robot, while the control group is given 1 hr conventional gait training for the same time as the robot-assisted training group. In all participants in each group, no other robot-assisted rehabilitation such as Lokomat, Erigo, or Morning Walk could be performed. |
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| Control Group | Other | - After the baseline test, the training is performed with 20 sessions in total (60 min / session); five sessions a week for four weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted Training | Other | The gait training in this study uses an exoskeletal wearable robot (Product name: ANGEL LEGS M20, Angel robotics, Co., Ltd.) consisting of a wearable part, a hip or knee joint gear providing the auxiliary force, and a controller backpack. This product is a powered orthopedic device for gait rehabilitation and treatment such as the lower limb muscle reconstruction and joint motion recovery in patients or handicapped individuals. The product consists of a power part, a controller part and a gear part, while the device is powered by an electric motor and the device motion induces the gait posture to support the lower limbs and allow the gait training to be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Ambulatory Category- Pre | - The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. | pre-treatment evaluation: before interventions approximately 5 days |
| Functional Ambulatory Category- Post | - The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. | post-treatment evaluation: after interventions approximately 5 days |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deogyoung Kim | Contact | +82 2-2228-3714 | KIMDY@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Deogyoung Kim | Department and Research Institute of Rehabilitation Medicine Yonsei University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41906440 | Derived | Lee JW, Chang WH, Kim TW, Kim HS, Hanapiah FA, Han SH, Jia CW, Kim DH, Kim DY. Patient-Centered Selection Criteria for Robot-Assisted Gait Training in Subacute Stroke: A Focus of User Satisfaction. NeuroRehabilitation. 2026 Jun;58(4):600-611. doi: 10.1177/10538135261436050. Epub 2026 Mar 29. | |
| 41424275 | Derived |
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| Conventional Therapy | Other | The conventional gait rehabilitation has been performed as a 1:1 training session between the therapist and a stroke patient. |
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| Chang WH, Kim TW, Kim HS, Hanapiah FA, Lee JW, Han SH, Jia CW, Kim DH, Kim DY. Efficacy of Wearable Exoskeleton for Gait Recovery in Patients With Stroke: A Multicenter Randomized Controlled Trial. Stroke. 2026 Mar;57(3):577-586. doi: 10.1161/STROKEAHA.125.052763. Epub 2025 Dec 22. |
| 40188310 | Derived | Chang WH, Kim TW, Kim HS, Hanapiah FA, Lee JW, Han SH, Jia CW, Kim DH, Kim DY. Interim results of exoskeletal wearable robot for gait recovery in subacute stroke patients. Sci Rep. 2025 Apr 5;15(1):11671. doi: 10.1038/s41598-025-96084-6. |
| 37567748 | Derived | Chang WH, Kim TW, Kim HS, Hanapiah FA, Kim DH, Kim DY. Exoskeletal wearable robot on ambulatory function in patients with stroke: a protocol for an international, multicentre, randomised controlled study. BMJ Open. 2023 Aug 11;13(8):e065298. doi: 10.1136/bmjopen-2022-065298. |