Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061072) titled 'A study on the characteristics of body-searching movements in patients with personal neglect following stroke' on April 1.
Study Type:
Observational
Primary Sponsor:
Institute - Kio University
Condition:
Condition - Personal Neglect
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To quantify body exploration behavior during the Fluff Test in post-stroke personal neglect (PN) patients using markerless video analysis and inertial measurement units (IMU), and to characterize its features by comparing with healthy older adults and non-PN stroke patients.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Key inclusion criteria
Aged 18 years or older
First-ever right hemisphere stroke (ischemic or hemorrhagic)
Impairment in at least one of the following confirmed by neurological assessment: motor function, language, attention, or praxis
Sufficient arousal and attention to perform the task
Asymptomatic lacunar infarcts permitted up to 2 lesions with a diameter of <=15 mm each (recorded and considered during analysis)
Supplementary note
This study primarily targets patients with right hemisphere lesions; however, patients with left hemisphere lesions will also be included in the recording and analysis if personal neglect is confirmed.
Key exclusion criteria - Key exclusion criteria
Prior clinical stroke, multiple or large lacunar infarcts
History of head trauma
Difficulty performing the task or maintaining adequate arousal
Other severe neurological, psychiatric, or medical conditions
Clinically suspected dementia with difficulty following instructions (MMSE <=21 as a guide; however, patients are not uniformly excluded solely due to aphasia or attentional impairment)
Severe illness with a prognosis of less than 1 year
Contraindications to MRI (e.g., claustrophobia, metallic foreign bodies)
Severe visual field deficits (homonymous hemianopia and quadrantanopia are included but recorded)
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 31 Day
Date of IRB - 2026 Year 04 Month 01 Day
Anticipated trial start date - 2026 Year 04 Month 01 Day
Last follow-up date - 2031 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069883
Disclaimer: Curated by HT Syndication.