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

NCT07057700 | Not Yet Recruiting

• 1 other identifier: 2025230
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Walking Impairment

Keywords

stroke; Lower limb dysfunction; robotics; gait

Outcome Measures

Primary Outcomes (1)

• 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.

  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);

Secondary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

welwalk training

EXPERIMENTAL

Daily physiotherapy training using the welwalk lower limb walking training robot

Device: welwalk training

conventional physical therapy

ACTIVE COMPARATOR

Daily training using traditional physiotherapy such as core training, gait training, etc.

Other: physical therapy

Interventions

welwalk training DEVICE

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.

welwalk training

physical therapy OTHER

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.

conventional physical therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine,

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (14)

• Zhang B, Li D, Liu Y, Wang J, Xiao Q. Virtual reality for limb motor function, balance, gait, cognition and daily function of stroke patients: A systematic review and meta-analysis. J Adv Nurs. 2021 Aug;77(8):3255-3273. doi: 10.1111/jan.14800. Epub 2021 Mar 6.

  PMID: 33675076 BACKGROUND

• Wang C, Zhang Q, Hou S, Guo D, Han X, Huo W, Zhang Y. Split-belt treadmill training improves gait symmetry and lower limb function in patients with stroke. Sci Rep. 2025 May 8;15(1):16123. doi: 10.1038/s41598-025-98322-3.

  PMID: 40341197 BACKGROUND

• Sheng Y, Han J. Biomechanical characteristics and neuromuscular action control mechanism of single-dual-task walking-conversion training in stroke patients. J Back Musculoskelet Rehabil. 2025 May;38(3):576-592. doi: 10.1177/10538127241308215. Epub 2025 Feb 12.

  PMID: 39973293 BACKGROUND

• Caliandro P, Molteni F, Simbolotti C, Guanziroli E, Iacovelli C, Reale G, Giovannini S, Padua L. Exoskeleton-assisted gait in chronic stroke: An EMG and functional near-infrared spectroscopy study of muscle activation patterns and prefrontal cortex activity. Clin Neurophysiol. 2020 Aug;131(8):1775-1781. doi: 10.1016/j.clinph.2020.04.158. Epub 2020 May 18.

  PMID: 32506008 BACKGROUND

• Li X, Zhang H, Zhang W, Wu J, Dai L, Long N, Jin T, Gu L, Chen J. Neural mechanisms underlying the improvement of gait disturbances in stroke patients through robot-assisted gait training based on QEEG and fNIRS: a randomized controlled study. J Neuroeng Rehabil. 2025 Jun 18;22(1):136. doi: 10.1186/s12984-025-01656-2.

  PMID: 40533805 BACKGROUND

• Belda-Lois JM, Mena-del Horno S, Bermejo-Bosch I, Moreno JC, Pons JL, Farina D, Iosa M, Molinari M, Tamburella F, Ramos A, Caria A, Solis-Escalante T, Brunner C, Rea M. Rehabilitation of gait after stroke: a review towards a top-down approach. J Neuroeng Rehabil. 2011 Dec 13;8:66. doi: 10.1186/1743-0003-8-66.

  PMID: 22165907 BACKGROUND

• Fan T, Zheng P, Zhang X, Gong Z, Shi Y, Wei M, Zhou J, He L, Li S, Zeng Q, Lu P, Zhao Y, Zou J, Chen R, Peng Z, Xu C, Cao P, Huang G. Effects of exoskeleton rehabilitation robot training on neuroplasticity and lower limb motor function in patients with stroke. BMC Neurol. 2025 May 3;25(1):193. doi: 10.1186/s12883-025-04203-7.

  PMID: 40319228 BACKGROUND

• Chen S, Zhang W, Wang D, Chen Z. How robot-assisted gait training affects gait ability, balance and kinematic parameters after stroke: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2024 Jun;60(3):400-411. doi: 10.23736/S1973-9087.24.08354-0. Epub 2024 Apr 22.

  PMID: 38647534 BACKGROUND

• Hao QH, Qiu MM, Wang J, Tu Y, Lv ZH, Zhu TM. The effect of lower limb rehabilitation robot on lower limb -motor function in stroke patients: a systematic review and meta-analysis. Syst Rev. 2025 Mar 26;14(1):70. doi: 10.1186/s13643-025-02759-6.

  PMID: 40140968 BACKGROUND

• Zhang S, Fan L, Ye J, Chen G, Fu C, Leng Y. An Intelligent Rehabilitation Assessment Method for Stroke Patients Based on Lower Limb Exoskeleton Robot. IEEE Trans Neural Syst Rehabil Eng. 2023;31:3106-3117. doi: 10.1109/TNSRE.2023.3298670. Epub 2023 Aug 2.

  PMID: 37490379 BACKGROUND

• Hesse S, Mehrholz J, Werner C. Robot-assisted upper and lower limb rehabilitation after stroke: walking and arm/hand function. Dtsch Arztebl Int. 2008 May;105(18):330-6. doi: 10.3238/arztebl.2008.0330. Epub 2008 May 2.

  PMID: 19629252 BACKGROUND

• Xu S, Zhu S, Li M, Zhang T, Wang Q, Sui Y, Shen Y, Chaojie K, Zhuang R, Guo C, Wang T, Zhu L. Altered cortical activation patterns in post-stroke patients during walking with two-channel functional electrical stimulation: a functional near-infrared spectroscopy observational study. Front Neurol. 2025 Jan 13;15:1449667. doi: 10.3389/fneur.2024.1449667. eCollection 2024.

  PMID: 39871991 BACKGROUND

• Rodriguez-Fernandez A, Lobo-Prat J, Font-Llagunes JM. Systematic review on wearable lower-limb exoskeletons for gait training in neuromuscular impairments. J Neuroeng Rehabil. 2021 Feb 1;18(1):22. doi: 10.1186/s12984-021-00815-5.

  PMID: 33526065 BACKGROUND

• Scrivener K, Dorsch S, McCluskey A, Schurr K, Graham PL, Cao Z, Shepherd R, Tyson S. Bobath therapy is inferior to task-specific training and not superior to other interventions in improving lower limb activities after stroke: a systematic review. J Physiother. 2020 Oct;66(4):225-235. doi: 10.1016/j.jphys.2020.09.008. Epub 2020 Oct 14.

  PMID: 33069609 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Ming Kang, master of science

CONTACT

+8615830039916; km04514@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 10, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Starting 6 months after publication
• Access Criteria: Authorized professional researchers, including but not limited to researchers engaged in neuroscience research who have obtained data access permission from their affiliated institutions, and clinical doctors from other medical institutions that have a cooperative relationship with this study and have signed data confidentiality agreements. They can access the detailed clinical medical histories of the participants, including past disease histories and treatment process records; neurological function assessment scale data; as well as imaging data collected during the study, such as brain magnetic resonance imaging (MRI) results. However, sensitive information related to participants' privacy, such as names, ID numbers, and contact information, will be strictly anonymized to ensure that such information cannot be obtained. They can contact the corresponding author or the first author via email.

Locations

CN (1)