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

Not Applicable

Not yet recruiting

• Conditions: Stroke; Walking Impairment

• Registration Number: NCT07057700
• Lead Sponsor: Ruijin Hospital

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-06-23
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10
• Primary Completion: 2027-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
functional near - infrared spectroscopy (fNIRS)	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)	Using fNIRS technology to observe brain activation and brain network changes during the walking period in participants.
10 Meter Walk Test(10WMT)	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)	assessing the participants' walking ability. Less time spent by patients indicates better walking ability.
Timed Up and Go Test (TUGT)	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)	Assessment of motor function of the unaffeected and affected steering sides
6minute walking test(6MWT)	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)	Assessment of cardiorespiratory endurance in participants
Berg Balance Scale (BBS)	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)	Assessment of the participant's ability to balance. The BBS is scored on a scale of 0 to 56; higher scores reflect better balance function.
Modified Barthel Index,MBI	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)	Assessment of the subject's ability to perform daily living tasks.The MBI is scored on a scale of 0 to 100; higher scores reflect better ADL.

Trial Locations

Locations (1)

Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine,; 🇨🇳 Shanghai, Shanghai, China