Safety and Efficacy of Multisensory Stimulation Virtual Reality for Stroke Patients.
NCT ID: NCT06275516
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-03-20
2026-07-31
Brief Summary
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Detailed Description
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The screening period include the verification of inclusion/exclusion criteria and the acquisition of informed consent.
Baseline and endpoint assessment period include motor function related scales were evaluated (muscle strength, muscle tone, Fugl-Meyer scale, Berg balance scale); cognitive function related scale assessment \[Brief Mental State Examination Scale (MMSE), Montreal Cognitive Assessment (MoCA), drawing clock test, Shape connection test A.B, standardized digital modal experiment, auditory word Learning Test\], emotional correlation scale assessment (Hamilton Depression Scale, Hamilton Anxiety Scale), and activity of daily living scale ADL scale. Meanwhile, quantitative evaluation of motor function three-dimensional gait detection and assessment of brain functional activation (fNIRs tests and fMRI) were synchronously completed.
The intervention period included multi-sensory stimulation immersive VR+ treadmill training with suitable for training intensity in the experimental group and only treadmill training similarly with suitable for training intensity in the control group. 20 minutes a day for 30 days, a total of 600 minutes (training frequency is adjusted according to the patient's own conditions).
Preliminary validation of effectiveness assessment includes Fugl-Meyer scale, Berg balance scale, and three-dimensional gait detection. Preliminary validation of the safety assessment includes fall and dizzy incidents.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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VR+treadmill training group
Multi-sensory stimulation immersive VR+ treadmill training with suitable for training intensity. 20 minutes a day for 30 days, a total of 600 minutes (training frequency is adjusted according to the patient's own conditions).
multi-sensory stimulation immersive VR+ treadmill training
Treadmill training with multi-sensory stimulation immersive VR in VR+treadmill training group
treadmill training group
Only treadmill training similarly with suitable for training intensity in the control group. 20 minutes a day for 30 days, a total of 600 minutes (training frequency is adjusted according to the patient's own conditions).
treadmill training
Only treadmill training in treadmill training group
Interventions
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multi-sensory stimulation immersive VR+ treadmill training
Treadmill training with multi-sensory stimulation immersive VR in VR+treadmill training group
treadmill training
Only treadmill training in treadmill training group
Eligibility Criteria
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Inclusion Criteria
2. 18-85 years old
3. Be able to walk with minor assistance
4. Can tolerate the rehabilitation training of this experiment
5. First stroke
6. Be able to follow instructions to complete the test
7. Patients who signed informed consent
Exclusion Criteria
2. There is a serious mental illness resulting in inability to cooperate with or tolerate this test
3. is participating in another clinical trial involving an investigational drug or physical therapy
4. Patients who have not signed informed consent
18 Years
85 Years
ALL
No
Sponsors
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First Affiliated Hospital of Chongqing Medical University
OTHER
Responsible Party
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Dingqun Bai
First Affiliated Hospital of Chongqing Medical University
Principal Investigators
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Dingqun Bai
Role: STUDY_CHAIR
First Affiliated Hospital of Chongqing Medical University
Locations
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The First Affiliated Hospital of Chongqing Medical University, First Branch
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-208
Identifier Type: -
Identifier Source: org_study_id
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