AzTrials
AzTrials

StrokeNCT06275516

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

A study testing multi-sensory stimulation immersive VR+ treadmill training and treadmill training in people with Stroke, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke
What is being tested?
multi-sensory stimulation immersive VR+ treadmill training and treadmill training
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
20 Mar 2024to 30 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dingqun Bai contact

023-89011334

baidingqun2014@163.com

Zheng Yang contact

zhengyangvivi@gmail.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Chongqing Medical University, First Branch

    Chongqing, Chongqing Municipality, 400016

    Ding Qun Bai, Ph.D., 023-89011334, baidingqun@hospital.cqmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Stroke
Being tested
multi-sensory stimulation immersive VR+ treadmill training, treadmill training
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • multi-sensory stimulation immersive VR+ treadmill trainingDevice

    Treadmill training with multi-sensory stimulation immersive VR in VR+treadmill training group

  • treadmill trainingDevice

    Only treadmill training in treadmill training group

Study groups in NCT06275516
Study groupRoleWhat they receive
VR+treadmill training groupExperimentalMulti-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).
Receives: Device: multi-sensory stimulation immersive VR+ treadmill training
treadmill training groupActive comparatorOnly 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).
Receives: Device: treadmill training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 days (Adjust according to the actual situation of patients)

Secondary outcomes (5)

  1. 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.

    Measured: 30 days (Adjust according to the actual situation of patients)

  2. 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.

    Measured: 30 days (Adjust according to the actual situation of patients)

  3. 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.

    Measured: 30 days (Adjust according to the actual situation of patients)

  4. 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.

    Measured: 30 days (Adjust according to the actual situation of patients)

  5. 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.

    Measured: 30 days (Adjust according to the actual situation of patients)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2024
  2. Study start20 Mar 2024
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06275516
Sponsor's protocol ID
2024-208
Status last verified
Mar 2026
First submitted
17 Feb 2024
Last updated
19 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Yang Z, Lu Q, Chen D, Tang L, Ran T, Yang L, Bai D. Multidimensional effects of virtual reality on motor dysfunction in patients who had a stroke: study protocol for a prospective, randomised, controlled clinical trial. BMJ Open. 2026 Apr 3;16(4):e108362. doi: 10.1136/bmjopen-2025-108362.

    PubMed 41932701

Questions about this trial

What is this clinical trial studying?

A study testing multi-sensory stimulation immersive VR+ treadmill training and treadmill training in people with Stroke, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dingqun Bai (023-89011334, baidingqun2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Assessment- Lower Extremity (time frame: 30 days (Adjust according to the actual situation of patients)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06275516, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in