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
1 other identifier
interventional
40
1 country
1
Brief Summary
This was a single-blind randomized controlled trial of multisensory stimulation virtual reality to improve motor and cognitive dysfunction in stroke patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Mar 2024
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2024
CompletedFirst Posted
Study publicly available on registry
February 23, 2024
CompletedStudy Start
First participant enrolled
March 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
March 19, 2026
March 1, 2026
2.3 years
February 17, 2024
March 16, 2026
Conditions
Outcome Measures
Primary Outcomes (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.
30 days (Adjust according to the actual situation of patients)
Secondary Outcomes (5)
Functional Near-Infrared Spectroscopy Detection - Supplementary Motor Area - Oxygenated Hemoglobin (fNIRS Detection - SMA - HbO2)
30 days (Adjust according to the actual situation of patients)
Berg balance scale
30 days (Adjust according to the actual situation of patients)
3D Gait Analysis - Affected Side Step Width
30 days (Adjust according to the actual situation of patients)
Montreal Cognitive Assessment（MoCA）
30 days (Adjust according to the actual situation of patients)
Mini-Mental State Examination (MMSE)
30 days (Adjust according to the actual situation of patients)
Other Outcomes (2)
Fall incidents
30 days (Adjust according to the actual situation of patients)
Dizzy incidents
30 days (Adjust according to the actual situation of patients)
Study Arms (2)
VR+treadmill training group
EXPERIMENTALMulti-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).
treadmill training group
ACTIVE 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).
Interventions
Treadmill training with multi-sensory stimulation immersive VR in VR+treadmill training group
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Chongqing Medical University, First Branch
Chongqing, Chongqing Municipality, 400016, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dingqun Bai
First Affiliated Hospital of Chongqing Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Clinical Professor
Study Record Dates
First Submitted
February 17, 2024
First Posted
February 23, 2024
Study Start
March 20, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
July 30, 2026
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- 2027.6.30
- 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.
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.