Investigating the Mechanisms of Welwalk Robot in Restoring Motor Function of the Lower Extremities in Stroke Patients

Launched by RUIJIN HOSPITAL · Jul 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a robotic device called Welwalk can help stroke patients improve their ability to walk by exploring how it affects the brain and leg movement. While we know that robotic walking training can improve walking and balance after a stroke, this study aims to better understand how the brain’s activity changes during this therapy. Researchers will use special brain imaging tools alongside tests that measure walking and leg function to see how Welwalk compares to traditional rehabilitation methods.

People eligible to join this study are adults who have had their first stroke within the past year, have weakness on one side of the body, and can follow simple instructions. Participants should weigh between 40 and 80 kg and have no severe muscle stiffness or other serious health problems like heart or lung disease. Those who join will take part in walking training using the Welwalk robot or standard therapy, and their brain activity and leg function will be carefully monitored. This study is not yet recruiting, but it hopes to provide new insights into how robotic therapy helps stroke recovery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • A history of myocardial infarction
• • Muscular or neurological disorder including diabetic neuropathy
• • Symptomatic angina or arrhythmia
• • Symptomatic respiratory disorder
• • Communicable infection
• • 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
• • 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
• • 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