NCT06850584

Validation Study of Simplified Chinese Version of LOTCA Scale in the Assessment of Cognitive Impairment in Patients with Traumatic Brain Injury

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Nanjing Broad Biopharmaceutical Ltd. · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
OTHER	Observation	The study was observational and did not involve any intervention.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-02-27
• Last updated: 2025-02-27

Locations

4 sites across 1 country: China