跳至主要内容
临床试验/NCT05433558
NCT05433558招募中不适用

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

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
behavioral indicators

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Experimental group

Experimental

enter the experiment directly

干预措施: Neuropsychological Rehabilitation (Other)

Waiting group

Experimental

enter the experiment after waiting eight weeks

干预措施: Neuropsychological Rehabilitation (Other)

结局指标

主要结局

behavioral indicators

时间窗: 10 weeks

Questionnaire

neurophysiological indicators

时间窗: 10 weeks

EEG power in beta and theta band

neuropsychological indicators

时间窗: 10 weeks

neuropsychological test

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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