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

NCT05433558 | Unknown

• 1 other identifier: A-ER-110-145
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acquired Brain Injury; Neuropsychological Rehabilitation; Caregiver

Outcome Measures

Primary Outcomes (3)

• neurophysiological indicators

  EEG power in beta and theta band

  10 weeks

• neuropsychological indicators

  neuropsychological test

  10 weeks

• behavioral indicators

  Questionnaire

  10 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

enter the experiment directly

Other: Neuropsychological Rehabilitation

Waiting group

EXPERIMENTAL

enter the experiment after waiting eight weeks

Other: Neuropsychological Rehabilitation

Interventions

Neuropsychological Rehabilitation OTHER

Neuropsychological Rehabilitation

Experimental group; Waiting group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

Nai-Wen, Guo

Tainan, East Dist., 701, Taiwan

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Nai-Wen Guo, Professor

CONTACT

+886-6-2353535; austing@ncku.edu.tw

Wun-Lin Huang, Master

CONTACT

+886-6-2353535; s86091019@gs.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 27, 2022
• Study Start: January 15, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 4, 2022

Record last verified: 2022-08

Locations

TW (1)