Effectiveness of Neuropsychological Rehabilitation Program for Disease of Adaptation in Patients With Acquired Brain Injury and Caregivers

Acquired Brain Injury Clinical Trial

Official title:

Effectiveness of Neuropsychological Rehabilitation Program for Disease of Adaptation in Patients With Acquired Brain Injury and Caregivers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05433558
• Other study ID #: A-ER-110-145
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2022
• Source: National Cheng-Kung University Hospital
• Contact: Nai-Wen Guo, Professor
• Phone: +886-6-2353535
• Email: austing[@]ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acquired brain injury is mental function damage caused by different reasons (such as cerebral neuropathy, head injury, traumatic brain injury, stroke, brain tumor, etc.). After the injury, patient has mental, cognitive, behavioral, body function, and other impairments, which makes patient still need the assistance of family members. For patients with brain injury in subacute stage, clinician assesses their needs for follow-up rehabilitation intervention programs in an appropriate way to assist patients who have the potential to return home to make care plans. In the process of rehabilitation, family members support patients, accompany patients to face and cope with changes in physical, cognitive, emotional, and behavioral aspects, and help patients return to life, which is the key factor for successful rehabilitation. When family members have good coping strategies, they will also have a better mood and quality of life, which will also contribute to the rehabilitation process of patients. Therefore, it is necessary to understand the psychological coping strategies used by family caregivers in the care process and the neuropsychological function of patients. This study is divided into three stages. In the first stage, it is expected to receive 30 groups of patients and their families. Semi-structured in-depth interviews and questionnaires will be conducted for caregivers of family members with brain injury, to explore the psychological adjustment strategies developed by family caregivers in the process of care, and neuropsychological assessment will be conducted for patients to understand the impact of disease on patients' neuropsychological functions, to serve as the direction of neuropsychological intervention. In the second stage, 230 family members of patients are expected to be collected. According to the psychological adjustment strategy framework constructed in phase I, appropriate neuropsychological tests and self-report questionnaires are selected to evaluate the family members of patients, and the scale is compiled. In the third stage, it is expected to collect 60 groups of patients and their families. Through screening tests, the ecological neuropsychological intervention will be carried out for those who have an insufficient psychological function or psychological distress, and the results of neuropsychological function and psychological status before and after the intervention will be tested with evaluation tools. The objective of this study is to provide a specific framework for clinical workers and families of patients with brain injury to face difficulties together and to increase the direction of clinical psychological intervention in the future.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Patient meet ICD of brain injury
• Three months after the patient was injured
• Patient's coma score > 8
• Patient's RLAL?5
• Patients are between 15-50 years old
• Caregiver is older than 20 years
• Caregiver can speak Mandarin or Taiwanese

Exclusion Criteria:

• Patient has developmental delay, neurological history, psychiatric history, substance abuse history, aphasia
• Caregiver has disability identification of Mental Functions and Structures of the Nervous System

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Caregiver
• Wounds and Injuries

Intervention

Other:
• Neuropsychological Rehabilitation
Neuropsychological Rehabilitation

Locations

Country	Name	City	State
Taiwan	Nai-Wen, Guo	Tainan	East Dist.

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neurophysiological indicators	EEG power in beta and theta band	10 weeks
Primary	neuropsychological indicators	neuropsychological test	10 weeks
Primary	behavioral indicators	Questionnaire	10 weeks