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StrokeNCT07057700

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

A study testing welwalk training and physical therapy in people with Stroke and Walking Impairment, run by Ruijin Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Stroke, Walking Impairment
What is being tested?
welwalk training and physical therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteChina
Study dates
1 Jul 2025to 1 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ming Kang, master of science contact

+8615830039916

km04514@rjh.com.cn

China1 site
  • Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine,

    Shanghai, Shanghai Municipality, 200025

    Jian Li, +86-137 0165 7578, lj12116@rih.com.cn

Other trials in China

About this study

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.

Read the 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.

Being tested
welwalk training, physical therapy
Keywords
stroke, Lower limb dysfunction, robotics, gait
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • welwalk trainingDevice

    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 therapyOther

    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.

Study groups in NCT07057700
Study groupRoleWhat they receive
welwalk trainingExperimentalDaily physiotherapy training using the welwalk lower limb walking training robot
Receives: Device: welwalk training
conventional physical therapyActive comparatorDaily training using traditional physiotherapy such as core training, gait training, etc.
Receives: Other: physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. functional near - infrared spectroscopy (fNIRS)

    Using fNIRS technology to observe brain activation and brain network changes during the walking period in participants.

    Measured: 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)

  2. 10 Meter Walk Test(10WMT)

    assessing the participants' walking ability. Less time spent by patients indicates better walking ability.

    Measured: 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)

  3. Timed Up and Go Test (TUGT)

    Assessment of motor function of the unaffeected and affected steering sides

    Measured: 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)

  4. 6minute walking test(6MWT)

    Assessment of cardiorespiratory endurance in participants

    Measured: 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)

  5. 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.

    Measured: 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)

  6. 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2025
  2. Study start1 Jul 2025 (estimated)
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07057700
Sponsor's protocol ID
2025230
Status last verified
Jul 2025
First submitted
23 Jun 2025
Last updated
10 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will share the demographic information and baseline clinical data of all participants.

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 38647534
  • 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.

    PubMed 40140968
  • 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.

    PubMed 37490379
  • 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.

    PubMed 19629252
  • 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.

    PubMed 39871991
  • 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.

    PubMed 33526065
  • 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.

    PubMed 33069609

Questions about this trial

What is this clinical trial studying?

A study testing welwalk training and physical therapy in people with Stroke and Walking Impairment, run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ming Kang, master of science (+8615830039916, km04514@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Functional Ambulation Categories (FAC) (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);). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07057700, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.

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