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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Другое 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.

Первичные конечные точки

• The Functional Ambulation Categories (FAC) [Срок оценки: 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);]

Вторичные конечные точки (6)

• functional near - infrared spectroscopy (fNIRS) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

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

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07057700 · 2025230

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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