welwalk training: welwalk training group 30 min of welwalk robot-assisted training + 15 min of walking training + 15 min of other training per session.The intervention lasted a total of 3 weeks, 6 sessions/week, 1 hour/session.
physical therapy: 45 min of walking training + 15 min of other training per session. The intervention lasted a total of 3 weeks, 6 sessions/week, 1 hour/session.
Study summary
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.
Eligibility
Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
The Functional Ambulation Categories (FAC) — Before intervention (Week 0); After the First week of intervention (Week 1); After the Second week of intervention (Week 2); After the Third week of intervention (Week 3); FAC is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.The FAC uses a six-point scale from 0 to 5, where a higher score indicates better performance.
Trial sites (1)
Facility
City
Region
Status
Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine,
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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