NCT07057700Not yet recruiting
Investigating the Mechanisms of Welwalk Robot in Restoring Motor Function of the Lower Extremities in Stroke Patients
Source: ClinicalTrials.gov · Last updated 10 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 23 Jun 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- Ruijin Hospital
- Diseases
- Stroke
- NCT number
- NCT07057700
What you commit to
- Study type: Interventional
- Planned participants: 38
- From 1 Jul 2025 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine, Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.