An interventional study of welwalk training and physical therapy in Stroke and Walking Impairment, sponsored by Ruijin Hospital. Not yet recruiting at 1 site in China. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
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.
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.
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 38 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Daily physiotherapy training using the welwalk lower limb walking training robot
Device: welwalk training
Daily training using traditional physiotherapy such as core training, gait training, etc.
Other: physical therapy
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.
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.
The Functional Ambulation Categories (FAC)
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.
Time frame: 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);
functional near - infrared spectroscopy (fNIRS)
Using fNIRS technology to observe brain activation and brain network changes during the walking period in participants.
Time frame: 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)
10 Meter Walk Test(10WMT)
assessing the participants' walking ability. Less time spent by patients indicates better walking ability.
Time frame: 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)
Timed Up and Go Test (TUGT)
Assessment of motor function of the unaffeected and affected steering sides
Time frame: 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)
6minute walking test(6MWT)
Assessment of cardiorespiratory endurance in participants
Time frame: 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)
Berg Balance Scale (BBS)
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.
Time frame: 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)
Modified Barthel Index,MBI
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.
Time frame: 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)
Plan to share: Yes — We will share the demographic information and baseline clinical data of all participants.
Supporting information: Study protocol, Sap, Analytic code
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Ruijin Hospital