UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058806 |
|---|---|
| Receipt number | R000066156 |
| Scientific Title | Quantitative Assessment of Perioperative Motor Function Using Virtual Reality in Patients with Myelopathy |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/15 12:57:10 |
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Basic information
Public title
Quantitative Assessment of Perioperative Motor Function Using Virtual Reality in Patients with Myelopathy
Acronym
Virtual Reality-based Myelopathy Motor METRY
Scientific Title
Quantitative Assessment of Perioperative Motor Function Using Virtual Reality in Patients with Myelopathy
Scientific Title:Acronym
The VR-MYOMETRY STUDY
Region
| Japan |
Condition
Condition
Patients with myelopathy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to explore the potential of virtual reality (VR) technology as a novel tool for quantitatively assessing motor function in patients with myelopathy undergoing surgical treatment. By comparing VR-based motor evaluations with conventional clinical assessments at preoperative and postoperative time points, this study seeks to validate the clinical utility of VR for perioperative functional monitoring and outcome prediction.
Basic objectives2
Others
Basic objectives -Others
To evaluate the correlation between conventional motor function assessments and VR-based motor evaluations at preoperative and 1-year postoperative time points in patients with myelopathy who undergo surgical treatment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between conventional motor function assessments and virtual reality (VR)-based evaluations at baseline (preoperative) and one year after surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Device used:Sony PlayStation VR2
VR headset
PlayStation VR2 Sense controllers (Left/Right) with straps
Patients with myelopathy scheduled for spinal surgery will undergo additional motor function assessments using virtual reality (VR) technology, in addition to routine clinical evaluations. Healthy volunteers will also undergo both conventional and VR-based assessments for comparative analysis. Patients will be evaluated preoperatively and at multiple postoperative time points.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Myelopathy group
1). Aged between 20 and 85 years, regardless of sex
2). Diagnosed with a spinal cord or spinal column disorder and scheduled to undergo surgical treatment
3). Able to participate in VR-based assessments and rehabilitation (i.e., capable of maintaining a seated position and performing required movements)
4). Provided written informed consent for participation in this study
Healthy volunteers group
1). Aged between 20 and 85 years, regardless of sex
2). No history of spinal cord or spinal column disorders
3). No impairments in motor function of the upper or lower extremities
4). Able to participate in VR-based assessments and rehabilitation (e.g., capable of maintaining a seated position and performing the required movements)
5). Provided written informed consent for participation in this study
Key exclusion criteria
1). Individuals with visual impairments
2). Individuals with hearing impairments
3). Individuals who are pregnant or suspected to be pregnant
4). Individuals deemed unsuitable for participation in the study by the investigator for medical or other reasons
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Honda |
Organization
Gunma University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
3718511
Address
3-39-15, Showa, Maebashi, Gunma
TEL
027-220-8273
ahonda0711@gmail.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Honda |
Organization
Gunma University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
3718511
Address
3-39-15, Showa, Maebashi, Gunma
TEL
027-220-8273
Homepage URL
ahonda0711@gmail.com
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Akira Honda
Funding Source
Organization
the Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Innovative Medical Research Center
Address
3-39-15, Showa-Machi, Maebashi City, Gunma
Tel
027-220-8740
amiura@gunma-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 15 | Day |
Last modified on
| 2025 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066156
