Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058806) titled 'Quantitative Assessment of Perioperative Motor Function Using Virtual Reality in Patients with Myelopathy' on Sept. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Gunma University
Condition:
Condition - Patients with myelopathy
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 20
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 Size - 45
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 01 Day
Anticipated trial start date - 2025 Year 09 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066156
Disclaimer: Curated by HT Syndication.