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

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.

Study Overview

• Status: Recruiting
• Conditions: Acquired Brain Injury; Neuropsychological Rehabilitation; Caregiver
• Intervention / Treatment: Other: Neuropsychological Rehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nai-Wen Guo, Professor; Phone Number: 5115 +886-6-2353535; Email: austing@ncku.edu.tw
• Study Contact Backup: Name: Wun-Lin Huang, Master; Phone Number: 5115 +886-6-2353535; Email: s86091019@gs.ncku.edu.tw

Study Locations

• Taiwan
  • East Dist.
    • Tainan, East Dist., Taiwan, 701
      • Recruiting
      • Nai-Wen, Guo
      • Contact: Wun-Lin Huang, Master; Phone Number: 5115 +886-6-2353535; Email: s86091019@gs.ncku.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group; enter the experiment directly	Other: Neuropsychological Rehabilitation; Neuropsychological Rehabilitation
EXPERIMENTAL: Waiting group; enter the experiment after waiting eight weeks	Other: Neuropsychological Rehabilitation; Neuropsychological Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neurophysiological indicators	EEG power in beta and theta band	10 weeks
neuropsychological indicators	neuropsychological test	10 weeks
behavioral indicators	Questionnaire	10 weeks

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2022
• Primary Completion (ANTICIPATED): December 31, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (ACTUAL): June 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: A-ER-110-145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No