UMIN-CTR Clinical Trial

Public title

Development of The Awareness Questionnaire(AQ) , self-awareness assessment method after acquired brain injury in Japan: Using Structural Equation and Item Response Models

Acronym

Development of AQ in Japan: Using Structural Equation and Item Response Models

Scientific Title

Development of The Awareness Questionnaire(AQ) , self-awareness assessment method after acquired brain injury in Japan: Using Structural Equation and Item Response Models

Scientific Title:Acronym

Development of AQ in Japan: Using Structural Equation and Item Response Models

Region

Japan

Condition

stroke patients

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to extend the master's research and to investigate in detail the Japanese version of the AQ scale according to COSMIN.

Basic objectives2

Others

Basic objectives -Others

By developing an assessment of self-awareness, it is possible to understand the symptoms and behavioral characteristics of patients from the perspective of self-awareness. As a result, it can be expected to consider appropriate interventions according to the degree of Self-awareness.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Japanese version of The Awareness Questionnaire

Key secondary outcomes

Glasgow Coma Scale, Mini Mental State Examination, Functional Independence Measure, Japanese version of Self Regulation Skills Interview, Trail Making Test, Wisconsin Card Sorting Test, digit span, Rey Osterrieth Complex Figure Test

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

90

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients diagnosed with stroke, patients who have given written consent to participate in the study, and patients who have the language ability to be assessed in this study.

Key exclusion criteria

Patients who do not meet selection criteria

Target sample size

350

Name of lead principal investigator

1st name	Chinaru
Middle name
Last name	Kajimoto

Organization

Itami Kousei Neurosurgery Hospital

Division name

Rehabilitation Department

Zip code

664-0028

Address

1-300-1, Nishino, Itami-shi, Hyogo, Japan

TEL

072-781-6600

Email

chinaruxfukuyama@gmail.com

Name of contact person

1st name	Chinaru
Middle name
Last name	Kajimoto

Organization

Itami Kousei Neurosurgery Hospital

Division name

Rehabilitation Department

Zip code

664-0028

Address

1-300-1, Nishino, Itami-shi, Hyogo, Japan

TEL

072-781-6600

Homepage URL

Email

chinaruxfukuyama@gmail.com

Institute

Osaka Metropolitan University

Institute

Department

Personal name

Organization

not applicable

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Osaka Metropolitan University Graduate School of Rehabilitation Science

Address

3-7-30, Habikino, Habikino, Osaka, Japan

Tel

072-950-2111

Email

chinaruxfukuyama@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

伊丹恒生脳神経外科病院（兵庫県），他

Date of disclosure of the study information

2022

Year

12

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2022

Year

09

Month

30

Day

Date of IRB

2022

Year

07

Month

31

Day

Anticipated trial start date

2022

Year

10

Month

01

Day

Last follow-up date

2023

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Patient information included age, gender, disease, injury hemisphere and site, dominant hand, education, days since onset, GCS, MMSE, and FIM for ADL. Efficacy outcomes were assessed using the SA measures: AQ Japanese version, Japanese SRSI, MMSE, TMT, WCST, digit span, and Rey-Osterrieth Complex Figure Test.
Structural validity was examined using Rasch analysis and covariance structure analysis. Rasch analysis assessed unidimensionality, local independence, and item fit (infit/outfit), and item difficulty (logits) was calculated to evaluate scale homogeneity. Exploratory factor analysis (maximum likelihood, promax rotation) and confirmatory factor analysis (CFI, TLI, RMSEA) assessed factor structure. Item response theory was applied to estimate item characteristic curves, test response and information functions, and item parameters using the EM-based marginal maximum likelihood method.
Reliability was evaluated using Cronbach's alpha. Validity of the Japanese AQ was assessed via Spearman's and Pearson's correlations with each measure, with and without normalization, and ceiling/floor effects were examined. Analyses were performed using R, JMP, Jamovi, and Amos, with a significance level of 0.05.

Registered date

2022

Year

12

Month

16

Day

Last modified on

2025

Year

09

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054504