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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

A history of myocardial infarction

Muscular or neurological disorder including diabetic neuropathy

Symptomatic angina or arrhythmia

Symptomatic respiratory disorder

Trial design

Treatments tested in this trial

  • welwalk training
  • physical therapy

Treatment groups

38 Participants
are divided into 2 treatment groups

Sponsors and collaborators