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NCT Number: NCT06850584

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

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huaian, Jiangsu, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Case group: Patients with traumatic brain injury

Inclusion criteria

  • Age> = 18 years old, male or female;
  • patients with traumatic brain injury;
  • The Mini-Mental State Examination (MMSE) score was lower than normal, and the cut-off value for diagnosis was determined according to different education levels: illiteracy (uneducated) <=19 points, primary school level <=22 points, junior high school level and above < = 26 points;
  • Voluntary participation and ability to complete the study and sign the informed consent form in accordance with the requirements of the study protocol.

Control group: family members or accompanying persons of patients in the same period

Inclusion criteria

  • Age> = 18 years old, male or female;
  • recent emotional stability;
  • Mini-Mental State Examination (MMSE) score was normal;
  • Voluntary participation and ability to complete the study and sign the informed consent form in accordance with the requirements of the study protocol.

Exclusion criteria

  • Case group: Patients with traumatic brain injury

Exclusion criteria

  • The study subject is in a lethargic state, coma, or persistent vegetative state;
  • the disease progresses rapidly or is accompanied by serious complications;
  • The subject has severe language dysfunction or/or bilateral upper limb motor function loss;
  • the study subject has severe visual and/or hearing impairment;
  • The subject has a severe mental disorder, physical weakness or other conditions (such as intolerance to the test or uncooperation, etc.);
  • Those who have a history of drug abuse within 6 months before screening or those who have used drugs within 3 months before screening;
  • Those who are considered by the investigator to be unsuitable to participate in this study or cannot complete this study for other reasons.

Control group: family members or accompanying persons of patients in the same period

Exclusion criteria

  • History of congenital or acquired central nervous system disease (including history of traumatic brain injury, cerebrovascular accident, etc.);
  • Those who have a history of drug abuse within 6 months before screening or who have used drugs within 3 months before screening;
  • Those who are considered by the investigator to be unsuitable to participate in this study or cannot complete this study for other reasons.

Treatment and study plan

observation

Other

The study was observational and did not involve any intervention.

Primary outcomes

  1. Evaluator Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery

    Time frame: At baseline

  2. Retest Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery

    Time frame: 2 weeks Later

  3. Internal Consistency Reliability of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery

    Time frame: At baseline

  4. Content Validity of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery

    Time frame: At baseline

  5. Construct Validity of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery

    Time frame: At baseline

  6. Discriminative Validity of the Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery

    Time frame: At baseline

  7. The change of Loewenston Occupational Therapy Cognitive Assessment (LOTCA) battery score from baseline values

    Time frame: 3 months later

  8. The change of Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 score from baseline values

    Time frame: 3 months later

  9. Correlation between LOTCA score change from baseline and ADAS-Cog11 score change from baseline

    Time frame: 3 months later

  10. The area under ROC curve and the sensitivity, specificity and Jorden index under optimal threshold of LOTCA score change from baseline value

    Time frame: 3 months later

Sponsors and collaborators

Lead sponsor

Nanjing Broad Biopharmaceutical Ltd.

Network

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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