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

In this study, participants will be randomly allocated into two groups: the Welwalk training group and the conventional rehabilitation therapy group.

Welwalk Training Group: Each session will consist of 30 minutes of Welwalk robot-assisted training, followed by 15 minutes of gait training and 15 minutes of supplementary exercises.Control Group (Conventional Rehabilitation Therapy): Each session will consist of 45 minutes of gait training and 15 minutes of supplementary exercises.The intervention period will span 3 weeks, with sessions administered six times per week. Each session will last 1 hour.

Clinical assessments will be conducted by certified healthcare professionals at four time points: at baseline (prior to the commencement of formal training), and after the 1st week, 2nd week, and 3rd week of treatment.

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