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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05433558
Enrollment
120
Registered
2022-06-27
Start date
2022-01-15
Completion date
2024-12-31
Last updated
2022-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Brain Injury, Caregiver, Neuropsychological Rehabilitation

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.

Interventions

Neuropsychological Rehabilitation

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
neurophysiological indicators10 weeksEEG power in beta and theta band
neuropsychological indicators10 weeksneuropsychological test
behavioral indicators10 weeksQuestionnaire

Countries

Taiwan

Contacts

Primary ContactNai-Wen Guo, Professor
austing@ncku.edu.tw+886-6-2353535
Backup ContactWun-Lin Huang, Master
s86091019@gs.ncku.edu.tw+886-6-2353535

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026