Tokyo, March 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060934) titled 'Development of an Exercise Evaluation Program Using Virtual Reality Devices for Unilateral Spatial Neglect' on March 16.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Kagoshima University

Condition: Condition - Healthy individual Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine whether the VR program we developed for USN is capable of evaluating USN just as effectively as conventional methods Basic objectives2 - Bio-equivalence

Intervention: Interventions/Control_1 - Participants will perform all three sets of VR programs in the assigned order. Each session lasts approximately 10 minutes. A washout period of at least 48 hours is observed between sessions. The intervention consists of a total of three sessions. The VR equipment used will be Vi-dere (Sysnet). This is a VR device approved as a medical device for USN assessment and training. Participants will wear VR goggles while seated in a chair. The surrounding environment will be designed so that there are no objects within the participants reach. Basic Task: Upon putting on the VR headset, participants can see the target object displayed within the VR space. Note that no objects other than the target are placed in the VR space. Participants hold the controller in their right (or left) hand, raise it above their head, and then perform a reaching movement toward the target object. The target disappears upon contact and reappears when the participant raises their hand above their head again. The target is positioned in one of three locations: front, right, or left. Visual deviation caused by the prism is uniformly set to 10 degrees to the right. Three Sets to Be Performed: Set 1 (Conventional Method Evaluation After 20 PA Trials): After performing 20 reaching trials with the prism (with the visual field shifted 10 degrees to the right), perform one reaching trial without the prism (with no visual field shift) on the 21st trial. After that, perform 10 reaching trials with the prism (for a total of 30 PA trials), followed by one reaching trial without the prism. Interventions/Control_2 - Set 2 (Conventional Method Evaluation after 30 PA trials): After performing 30 reaching trials with the prism, perform one reaching trial without the prism on the 31st trial.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Individuals with no history of stroke or higher brain dysfunction. Individuals who have provided written consent to participate in the study. Individuals aged 20 to 80 years old on the date consent is obtained (gender is not a factor). Individuals capable of understanding and following the instructions presented within the VR environment by the researcher. Key exclusion criteria - Individuals with a history of stroke. Individuals diagnosed with unilateral spatial neglect. Individuals with cognitive impairments that make it difficult to understand the study instructions. Individuals with upper limb paralysis, limited joint range of motion, or ataxia that would interfere with the performance of the reaching task. Individuals with severe visual impairment (uncorrectable) that affects task performance. Individuals who have previously experienced severe motion sickness or intense discomfort from VR use. Individuals who experienced intense discomfort during the trial VR session. Any other individuals deemed unsuitable for the study by the principal investigator. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 18 Day Date of IRB - 2025 Year 12 Month 16 Day Anticipated trial start date - 2026 Year 03 Month 17 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069732

Disclaimer: Curated by HT Syndication.