Safety and Efficacy of Multisensory Stimulation Virtual Reality for Stroke Patients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: multi-sensory stimulation immersive VR+ treadmill training, treadmill training.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Single-blind Randomized Controlled Trial of Multisensory Stimulation Virtual Reality to Improve Motor and Cognitive Function in Stroke Patients
Overview
This was a single-blind randomized controlled trial of multisensory stimulation virtual reality to improve motor and cognitive dysfunction in stroke patients.
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.
Interventions
- Device multi-sensory stimulation immersive VR+ treadmill training
Treadmill training with multi-sensory stimulation immersive VR in VR+treadmill training group - Device treadmill training
Only treadmill training in treadmill training group
Primary outcome measures
- Fugl-Meyer Assessment- Lower Extremity [Time frame: 30 days (Adjust according to the actual situation of patients)]
Secondary outcome measures (5)
- Functional Near-Infrared Spectroscopy Detection - Supplementary Motor Area - Oxygenated Hemoglobin (fNIRS Detection - SMA - HbO2) [Time frame: 30 days (Adjust according to the actual situation of patients)]
- Berg balance scale [Time frame: 30 days (Adjust according to the actual situation of patients)]
- 3D Gait Analysis - Affected Side Step Width [Time frame: 30 days (Adjust according to the actual situation of patients)]
- Montreal Cognitive Assessment（MoCA） [Time frame: 30 days (Adjust according to the actual situation of patients)]
- Mini-Mental State Examination (MMSE) [Time frame: 30 days (Adjust according to the actual situation of patients)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Chongqing Medical University, First Branch — Chongqing
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. PMID 41932701
Identifiers
NCT: NCT06275516 · 2024-208