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Validation Study of Simplified Chinese Version of LOTCA Scale in the Assessment of Cognitive Impairment in Patients with Traumatic Brain Injury
Sponsor: Nanjing Broad Biopharmaceutical Ltd.
Summary
In this study, 300 patients aged ≥18 years old with traumatic brain injury (case group) and hospitalized patients without central nervous system disease or their family members and accompanying staff (control group) were selected as the study objects. At baseline, participants completed the Mini-mental State Examination (MMSE), the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery, the Glasgow Coma Scale (GCS), and the Alzheimer's Disease Rating Scale Cognitive Subscale (ADAS-Cog11). The evaluation process of the first LOTCA test was videotaped by a person. 2 weeks after the evaluation, the same two scale raters watched the video and rated it independently again. After 3 months, the subjects completed MMSE, LOTCA battery, GCS, ADAS-Cog11 assessment again.
Official title: A Confirmatory Study of the Simplified Chinese Version of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) Battery (2nd Edition) to Assess Cognitive Impairment in Patients with Traumatic Brain Injury
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2025-03-01
Completion Date
2025-12-31
Last Updated
2025-02-27
Healthy Volunteers
Yes
Conditions
Interventions
Observation
The study was observational and did not involve any intervention.
Locations (4)
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
Huaian, Jiangsu, China
Suzhou Jiulong Hospital
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China