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Studying how a walking robot helps stroke patients regain leg movement

Tests a robotic gait trainer against usual therapy in adults recovering from stroke.

Key facts

Who runs it
Ruijin Hospital
Where
Shanghai, ChinaSee the site
Trial code
Registry title
Investigating the Mechanisms of Welwalk Robot in Restoring Motor Function of the Lower Extremities in Stroke Patients
Status
Not yet recruiting
People taking part
38 people, planned
Started
1 Jul 2025
Expected to end
1 Jun 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • welwalk training
  • physical therapy
Record updated
10 July 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 20 or older who had a first stroke (bleeding or blocked blood vessel in the brain) within the last year and have weakness on one side. It studies robot-assisted walking training.

Age
20 years or older
Sex
All sexes can join.
Disease stage
First stroke on one side of the brain (cerebral infarction or intracerebral hemorrhage), within 1 year of stroke onset, with one-sided weakness (hemiplegia). Muscle stiffness in hip, knee and ankle not too strong (Modified Ashworth Scale <3).
Earlier treatment
The trial is looking for people who are at risk of the leg giving way when walking with an ankle-foot orthosis (AFO).

Main reasons for not taking part

  • History of myocardial infarction (heart attack)
  • Muscle or nerve disease, including diabetic neuropathy
  • Joint contracture or limb deformity that affects walking
  • Uncontrolled high blood pressure or fast heart rate at rest
  • Pregnant patients

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

  • 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 take part

  • A history of myocardial infarction
  • Muscular or neurological disorder including diabetic neuropathy
  • Symptomatic angina or arrhythmia
  • Symptomatic respiratory disorder
  • Communicable infection
  • 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
  • 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
  • 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

Where in China

  • Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine,Shanghai, ChinaContact: Jian LiNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • welwalk trainingTreatment being tested

    Daily physiotherapy training using the welwalk lower limb walking training robot

  • conventional physical therapyExisting treatment, for comparison

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

    Treatment: physical therapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Investigating the Mechanisms of Welwalk Robot in Restoring Motor Function of the Lower Extremities in Stroke Patients
Plain-language title
Studying how a walking robot helps stroke patients regain leg movementGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
10 July 2025