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

Primary Purpose

Acquired Brain Injury, Neuropsychological Rehabilitation, Caregiver

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Neuropsychological Rehabilitation
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Brain Injury

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nai-Wen, GuoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental group

Waiting group

Arm Description

enter the experiment directly

enter the experiment after waiting eight weeks

Outcomes

Primary Outcome Measures

neurophysiological indicators
EEG power in beta and theta band
neuropsychological indicators
neuropsychological test
behavioral indicators
Questionnaire

Secondary Outcome Measures

Full Information

First Posted
June 14, 2022
Last Updated
November 2, 2022
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05433558
Brief Title
Effectiveness of Neuropsychological Rehabilitation Program for Disease of Adaptation in Patients With Acquired Brain Injury and Caregivers
Official Title
Effectiveness of Neuropsychological Rehabilitation Program for Disease of Adaptation in Patients With Acquired Brain Injury and Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury, Neuropsychological Rehabilitation, Caregiver

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
enter the experiment directly
Arm Title
Waiting group
Arm Type
Experimental
Arm Description
enter the experiment after waiting eight weeks
Intervention Type
Other
Intervention Name(s)
Neuropsychological Rehabilitation
Intervention Description
Neuropsychological Rehabilitation
Primary Outcome Measure Information:
Title
neurophysiological indicators
Description
EEG power in beta and theta band
Time Frame
10 weeks
Title
neuropsychological indicators
Description
neuropsychological test
Time Frame
10 weeks
Title
behavioral indicators
Description
Questionnaire
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nai-Wen Guo, Professor
Phone
+886-6-2353535
Ext
5115
Email
austing@ncku.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Wun-Lin Huang, Master
Phone
+886-6-2353535
Ext
5115
Email
s86091019@gs.ncku.edu.tw
Facility Information:
Facility Name
Nai-Wen, Guo
City
Tainan
State/Province
East Dist.
ZIP/Postal Code
701
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wun-Lin Huang, Master
Phone
+886-6-2353535
Ext
5115
Email
s86091019@gs.ncku.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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