Investigating the Mechanisms of Welwalk Robot in Restoring Motor Function of the Lower Extremities in Stroke Patients
NCT ID: NCT07057700
Last Updated: 2025-07-10
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
38 participants
INTERVENTIONAL
2025-07-01
2027-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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welwalk training
Daily physiotherapy training using the welwalk lower limb walking training robot
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.
conventional physical therapy
Daily training using traditional physiotherapy such as core training, gait training, etc.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Qing Xie, PhD
Professor
Locations
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Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine,
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2025230
Identifier Type: -
Identifier Source: org_study_id
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