Clinical Trial: Development of a simulated driving test with eye measurement for stroke and brain injury patients with hemispatial neglect (Japan)

Tokyo, Oct. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059298) titled 'Development of a simulated driving test with eye measurement for stroke and brain injury patients with hemispatial neglect' on Oct. 6.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Shinshu university

Condition: Condition - Stroke/brain injury Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study was to develop an objective index for determining whether a person can resume driving, using the results of the Stroke Driver's Screening Assessment Japanese Version (J-SDSA) as an external criterion, and using the gaze and measurement data (including neuropsychological tests and motor ability tests) of PSR, SPR, prefrontal cortex oxyHb, etc. in stroke and brain injury victims. The objective of this study is to develop an objective index to judge whether or not a person can resume driving, using the results of the Stroke Driver's Screening Assessment Japanese Version (J-SDSA) as an external criterion. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Driving simulators are done for all.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1 Stroke and brain injury victims aged 18 and over undergoing rehabilitation at Shinshu University Hospital. 2 Right hemisphere injury and right-handedness 3 Persons who are capable of performing the simulated driving test 4 Subjects who have given a full explanation of their participation in this study and who have given written consent of their own free will. 5 Persons who have a driving licence. Key exclusion criteria - Persons with severe visual impairment (reduced visual acuity: corrected vision less than 0.7 in both eyes, visual field constriction, visual blindness, colour weakness, etc.). Target Size - 60

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2023 Year 04 Month 01 Day Date of IRB - 2023 Year 05 Month 10 Day Anticipated trial start date - 2023 Year 05 Month 10 Day Last follow-up date - 2025 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059278

Disclaimer: Curated by HT Syndication.