Validation Study of Simplified Chinese Version of LOTCA Scale in the Assessment of Cognitive Impairment in Patients with Traumatic Brain Injury
Condition(s) studied
Investigational drug(s) / intervention(s)
Observation: The study was observational and did not involve any intervention.
Study 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.
Eligibility
Primary outcome measure(s)
- Evaluator Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery — At baseline
- Retest Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery — 2 weeks Later
- Internal Consistency Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery — At baseline
- Content Validity of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery — At baseline
- Construct Validity of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery — At baseline
- Discriminative Validity of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery — At baseline
- The change of Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery score from baseline values — 3 months later
- The change of Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 score from baseline values — 3 months later
- Correlation between LOTCA score change from baseline and ADAS-Cog11 score change from baseline — 3 months later
- The area under ROC curve and the sensitivity, specificity and Jorden index under optimal threshold of LOTCA score change from baseline value — 3 months later
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University | Huaian | Jiangsu | |
| Suzhou Jiulong Hospital | Suzhou | Jiangsu | |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | |
| Northern Jiangsu People's Hospital | Yangzhou | Jiangsu |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06850584 on ClinicalTrials.gov ↗ ← All trials in China