Safety and Efficacy of Multisensory Stimulation Virtual Reality for Stroke Patients.

NCT ID: NCT06275516

Last Updated: 2025-09-08

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-20

Study Completion Date

2026-07-31

Brief Summary

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This was a single-blind randomized controlled trial of multisensory stimulation virtual reality to improve motor and cognitive dysfunction in stroke patients.

Detailed Description

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This was single-blind randomized controlled intervention study. Each stroke subject underwent screening period, baseline assessment period, intervention period, endpoint assessment period.

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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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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).

Group Type EXPERIMENTAL

multi-sensory stimulation immersive VR+ treadmill training

Intervention Type DEVICE

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).

Group Type ACTIVE_COMPARATOR

treadmill training

Intervention Type DEVICE

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

Intervention Type DEVICE

treadmill training

Only treadmill training in treadmill training group

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of stroke by neuroimaging (CT or MRI) assessment
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

1. The test could not be tolerated due to organic disease
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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Dingqun Bai

First Affiliated Hospital of Chongqing Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Dingqun Bai

Role: CONTACT

023-89011334

Zheng Yang

Role: CONTACT

Facility Contacts

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Ding Qun Bai, Ph.D.

Role: primary

023-89011334

Other Identifiers

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2024-208

Identifier Type: -

Identifier Source: org_study_id

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