Tokyo, Sept. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059206) titled 'Effects of Virtual Reality-Based Sitting Balance Intervention on Subjective Postural Verticality and Brain Activity Dynamics' on Sept. 26.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Active
Primary Sponsor:
Institute - SBC Tokyo Medical University
Condition:
Condition - Patients with Stroke in hemiplegia, Pusher behavior and unilateral spatial neglect
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study is designed to develop VR-based assessment and intervention methods for SPV-EO and elucidate brain activity dynamics using fNIRS.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Conventional intervention
Interventions/Control_2 - Experimental intervention using Virtual Reality
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - No impairment of consciousness.
Ability to understand study instructions and provide written informed consent.
Presence of a unilateral supratentorial lesion.
Diagnosis of stroke hemiplegia, Pusher syndrome, or unilateral spatial neglect.
Stable neurological and medical condition/symptoms at the time of enrollment.
Key exclusion criteria - Severe dementia or aphasia that significantly impairs communication.
Diagnosis of neurodegenerative diseases (e.g., Parkinson's disease).
Unstable neurological symptoms or currently undergoing treatment that may interfere with study results.
Inability to understand or provide written informed consent.
Target Size - 34
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2023 Year 07 Month 07 Day
Date of IRB - 2023 Year 07 Month 07 Day
Anticipated trial start date - 2025 Year 04 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=R000067716
Disclaimer: Curated by HT Syndication.