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

A Single-blind Randomized Controlled Trial of Multisensory Stimulation Virtual Reality to Improve Motor and Cognitive Function in Stroke Patients

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

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: multi-sensory stimulation immersive VR+ treadmill training; Device: treadmill training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dingqun Bai; Phone Number: 023-89011334; Email: baidingqun2014@163.com
• Study Contact Backup: Name: Zheng Yang; Email: zhengyangvivi@gmail.com

Study Locations

• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400016
      • Recruiting
      • The First Affiliated Hospital of Chongqing Medical University, First Branch
      • Contact: Ding Qun Bai, Ph.D.; Phone Number: 023-89011334; Email: baidingqun@hospital.cqmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The first onset of stroke is diagnosed and confirmed according to the requirements of stroke
2. The Fugl-Meyer Assessment of Lower Extremity (FMA-LE) is less than 34.
3. 18-85 years of age.
4. Able to walk with minor assistance
5. MMSE score of 20-30 and ability to understand and follow instructions during the trial
6. Able to sign an informed consent form.

Exclusion Criteria:

1. Severe visual or hearing impairments.
2. Pregnant or breastfeeding women.
3. Patients with unrepaired cranial bone flaps or metallic implants following brain surgery.
4. Presence of other conditions affecting lower limb motor function, such as osteoarthritis or recent lower limb fractures.
5. History of severe psychiatric disorders, other neurological diseases, acute cardiopulmonary dysfunction, multiple organ failure, brain tumours, or epilepsy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: multi-sensory stimulation immersive VR+ treadmill training; Treadmill training with multi-sensory stimulation immersive VR in VR+treadmill training group
Active Comparator: 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).	Device: treadmill training; Only treadmill training in treadmill training group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment- Lower Extremity	The Fugl-Meyer Assessment of Motor Recovery after Stroke - Lower Extremity (FMA-LE) evaluates lower extremity motor impairment through 17 items assessing reflexes, synergy patterns, and coordination. Each item is scored 0-2 (total range 0-34), with higher scores indicating better motor function. The total is the sum of all items, including motor (0-30) and coordination (0-4) subcomponents.	30 days (Adjust according to the actual situation of patients)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Near-Infrared Spectroscopy Detection - Supplementary Motor Area - Oxygenated Hemoglobin (fNIRS Detection - SMA - HbO2)	Functional Near-Infrared Spectroscopy Detection - Supplementary Motor Area - Oxygenated Hemoglobin (fNIRS Detection - SMA - HbO2) measures cortical activation in the supplementary motor area via oxygenated hemoglobin concentration changes. Values are reported as changes from baseline in mmol/L, with increases indicating greater neural activity during motor tasks.	30 days (Adjust according to the actual situation of patients)
Berg balance scale	Berg Balance Scale (BBS) is a 14-item performance-based measure that assesses static and dynamic balance abilities in older adults or individuals with impaired balance function. Each item is rated on a 5-point ordinal scale ranging from 0 (unable to perform) to 4 (able to perform independently), yielding a total score range of 0 to 56, with higher scores indicating better balance and lower fall risk. The total score is calculated by summing all 14 individual item scores, and it is commonly used to evaluate balance impairment and predict fall risk in clinical populations.	30 days (Adjust according to the actual situation of patients)
3D Gait Analysis - Affected Side Step Width	3D Gait Analysis - Affected Side Step Width: This parameter measures the lateral distance between the two feet during walking, derived from three-dimensional motion analysis, focusing on the affected side. Units are centimeters (cm), with typical values ranging from approximately 5 to 20 cm depending on individual factors. Higher values represent wider step width, which may indicate balance deficits or compensatory strategies; lower values may also reflect instability. The clinical interpretation of better or worse outcomes is context-dependent.	30 days (Adjust according to the actual situation of patients)
Montreal Cognitive Assessment（MoCA）	Montreal Cognitive Assessment (MoCA) is a brief screening tool for mild cognitive impairment, evaluating visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. It comprises 30 items with a total score range of 0 to 30, where higher scores indicate better cognitive function (≥26 considered normal). The total is the sum of all subdomain scores.	30 days (Adjust according to the actual situation of patients)
Mini-Mental State Examination (MMSE)	Mini-Mental State Examination (MMSE) is a brief cognitive screening tool assessing orientation, registration, attention and calculation, recall, language, and visual construction. It consists of 30 items with a total score range of 0 to 30, where higher scores indicate better cognitive function (scores ≥24 are generally considered normal). The total score is calculated by summing all item scores.	30 days (Adjust according to the actual situation of patients)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall incidents	Safety assessment	30 days (Adjust according to the actual situation of patients)
Dizzy incidents	Safety assessment	30 days (Adjust according to the actual situation of patients)

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Chongqing Medical University
• Investigators: Study Chair: Dingqun Bai, First Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: February 17, 2024
• First Submitted That Met QC Criteria: February 17, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 2024-208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The deidentified individual participant data (IPD) that underlie the results reported in this study will be available beginning 6 months and ending 5 years after publication. Data will be shared with researchers who provide a methodologically sound proposal for use in individual participant data meta-analysis or replication of study findings. Proposals should be directed to corresponding author's email. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Time Frame: 2027.6.30
• IPD Sharing Access Criteria: Access Criteria: Data will be available to researchers who submit a scientifically sound proposal. Requestors must agree to use the data only for the stated research purpose and sign a data access agreement. Ethical approval may be required depending on the proposed study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No