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

NCT06850584 | Not Yet Recruiting DMC

• 1 other identifier: LOTCA-YZ-1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

Case group

Other: Observation

Control group

Other: Observation

Interventions

Observation OTHER

The study was observational and did not involve any intervention.

Case group; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Age ≥18 years old, male or female, patients with traumatic brain injury (case group) and family members or caregivers of patients at the same time (control group).

You may qualify if:

• \- Case group: Patients with traumatic brain injury
• 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
• 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.

You may not qualify if:

• \- Case group: Patients with traumatic brain injury
• 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
• 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.

Sponsors & Collaborators

• Nanjing Broad Biopharmaceutical Ltd.: lead

Study Sites (4)

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

Huaian, Jiangsu, China

Location

Suzhou Jiulong Hospital

Suzhou, Jiangsu, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Observation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• tong ru Yu

  The Affiliated Hospital of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 27, 2025
• Study Start: March 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)