Studying how a walking robot helps stroke patients regain leg movement
Tests a robotic gait trainer against usual therapy in adults recovering from stroke.
Plain-language title generated from the registry record
Registry title: Investigating the Mechanisms of Welwalk Robot in Restoring Motor Function of the Lower Extremities in Stroke Patients
Key facts
- Where
- Shanghai, ChinaSee the site
Where in China
- Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine,Shanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT07057700
- Record updated
- 10 July 2025
- Original description
Current evidence and clinical applications of robotic gait training devices for motor function recovery post-stroke are increasingly available. Although existing research demonstrates that robotic gait training can improve patients' gait and balance, there remains a lack of in-depth investigation into its specific mechanisms of action concerning central nervous system (CNS) reorganization - notably, changes in activity within the motor cortex and associated neural networks. The intrinsic changes within the CNS have received insufficient attention, limiting a comprehensive and profound understanding of the rehabilitation outcomes. Therefore, this study aims to elucidate the potential mechanisms underlying robotic gait training-induced neuroplasticity by integrating functional near-infrared spectroscopy (fNIRS) technology with multi-dimensional lower limb motor function assessment tools (such as FAC, BBS, AMEDA, 10MWT, 6MWT, TUGT). It will systematically investigate the effects of robotic gait training on both the central nervous system and lower limb motor function in stroke patients. Furthermore, the study will compare the differences in functional recovery efficacy between robotic gait training and conventional rehabilitation therapies.Read full original descriptionShow less
Investigating the Mechanisms of Welwalk Robot in Restoring Motor Function of the Lower Extremities in Stroke Patients
Current evidence and clinical applications of robotic gait training devices for motor function recovery post-stroke are increasingly available. Although existing research demonstrates that robotic gait training can improve patients' gait and balance, there remains a lack of in-depth investigation into its specific mechanisms of action concerning central nervous system (CNS) reorganization - notably, changes in activity within the motor cortex and associated neural networks. The intrinsic changes within the CNS have received insufficient attention, limiting a comprehensive and profound understanding of the rehabilitation outcomes. Therefore, this study aims to elucidate the potential mechanisms underlying robotic gait training-induced neuroplasticity by integrating functional near-infrared spectroscopy (fNIRS) technology with multi-dimensional lower limb motor function assessment tools (such as FAC, BBS, AMEDA, 10MWT, 6MWT, TUGT). It will systematically investigate the effects of robotic gait training on both the central nervous system and lower limb motor function in stroke patients. Furthermore, the study will compare the differences in functional recovery efficacy between robotic gait training and conventional rehabilitation therapies.
Inclusion: Patients or family gave written informed consents to participate in this study; Patients with first hemiplegia caused by primary supratentorial intracerebral hemorrhage or cerebral infarction; Within 1 year of stroke onset; Aged ≥ 20; Body weight is between 40 and 80 kg; No excessive spasticity in hip, knee, and ankle joints (Modified Ashworth Scale <3); sufficient cognition to follow simple instructions and to understand the content and purpose of the study (Chinese version-MOCA ≥ 20 points); Patients who have risks of giving-way when they walk with Ankle-Foot orthosis (AFO).
Exclusion: A history of myocardial infarction; Muscular or neurological disorder including diabetic neuropathy; Symptomatic angina or arrhythmia; Symptomatic respiratory disorder; Communicable infection; Inadequate control of hypertension (resting systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 120 mmHg); Inadequate control of tachycardia (heart rate at rest ≥ 120 bpm); Training restriction due to reduced cardiac function or respiratory dysfunction; Visual or auditory impairment hindering training; Joint contracture or limb deformity that affects walking (Range of motion of hip extension < 5 degree, knee extension < -5 degree (can be flexible), ankle dorsiflexion with knee extension position < 5 degree); Heterotropic ossification that restrict the range of motion of joints of lower extremities; Being vulnerable to fracture like severe osteoporosis of spine or lower extremities; Incontinence of urine or feces that may deface the robotic knee-ankle-foot device of Welwalk; Pregnant patients; Recent participation in other clinical trials; Patient whom examination doctor judge improper as a trial subject; Anyone not able to sustain the training protocol with Welwork or regular training.