Tokyo, Sept. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062864) titled 'Study of the Relationship Between Unilateral Spatial Neglect and the Effect of Prism Adaptation in Patients With Acute Stroke' on Sept. 9.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Nagasaki University
Condition:
Condition - Stroke
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate differences in the immediate effect of prism adaptation using virtual reality between patients with egocentric and allocentric unilateral spatial neglect after acute stroke.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants perform one prism adaptation task using a virtual reality system. The task consists of 20 reaches without prism deviation, 100 reaches with prism deviation, and 20 reaches without prism deviation. The x-axis deviation of the reaching position is measured immediately before and after the prism adaptation task to evaluate the after-effect.
Eligibility:
Age-lower limit - 5
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1.Patients with acute stroke admitted to the Stroke Center of Nagasaki University Hospital.
2.Patients with unilateral spatial neglect (USN) identified by the Behavioural Inattention Test (BIT) and Catherine Bergego Scale (CBS).
3.Patients who provide written informed consent after receiving an explanation of the study, or whose legally authorized representative provides consent.
Key exclusion criteria - 1.Individuals with a history of cerebrovascular disease
2.Individuals with brainstem lesions
3.Individuals with visual impairment (including those with untreated ophthalmic conditions)
4.Individuals exhibiting cognitive decline (Mini-Mental State Examination score of 15 or lower)
5.Individuals unable to maintain a seated position in a wheelchair, or those experiencing blood pressure fluctuations associated with maintaining a seated posture
6.Any other patients deemed unsuitable for the study by the principal investigator
Target Size - 60
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 07 Month 03 Day
Date of IRB - 2023 Year 11 Month 28 Day
Anticipated trial start date - 2025 Year 07 Month 15 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071808
Disclaimer: Curated by HT Syndication.