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

ConditionsStrokeWalking Impairment
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • welwalk training

    Device

    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

    Other intervention

    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.

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: welwalk trainingExperimental treatment 1 intervention
Group B: conventional physical therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

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);

Secondary outcomes

1

functional near - infrared spectroscopy (fNIRS)

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

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)
2

10 Meter Walk Test(10WMT)

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

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)
3

Timed Up and Go Test (TUGT)

Assessment of motor function of the unaffeected and affected steering sides

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)
4

6minute walking test(6MWT)

Assessment of cardiorespiratory endurance in participants

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: