Psychometric Evaluation of Commonly Used Measures in Stroke

NCT ID: NCT05530525

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-12-31

Brief Summary

Purposes: The aim of this study is to examine the psychometric properties (e.g. test-retest reliability, random measurement error, practice effect, and responsiveness) of the commonly used measures in patients with stroke using medical record review.

The investigators anticipate reviewing 1000 stroke patients' medical record from a medical center in Taiwan. The medical record will be reviewed by an experienced and well-trained occupational therapist.

Detailed Description

The investigators anticipate reviewing 1000 stroke patients' medical record (from 2018/6/1 to 2021/6/30) from a medical center in Taiwan. The medical record will be reviewed by an experienced and well-trained occupational therapist. The study was approved by the local institutional review board. Because the targeted populations for examining the test-retest reliability and responsiveness were different, the inclusion criteria were listed separately below.

Test-retest reliability Chronic stroke patients' data was reviewed to examine the test-retest reliability. The participants met the following criteria: (1) diagnosis of cerebral hemorrhage or cerebral infarction, (2) age ≥ 20 years, and (3) stroke onset ≥ 6 months (first and recurrent stroke included).

Responsiveness Subacute stroke patients' data was reviewed to examine the responsiveness. The participants met the following criteria: (1) diagnosis of cerebral hemorrhage or cerebral infarction, (2) age ≥ 20 years, and (3) stroke onset < 3 months (first and recurrent stroke included).

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Test-retest reliability and responsiveness group (All of the data was collected from medical record)

All the participants received conventional rehabilitation (e.g., occupational therapy, physical therapy, or speech therapy) or other interventions (e.g., acupuncture).

The Computerized Adaptive Testing system of the Functional Assessment of Stroke

Intervention Type: DIAGNOSTIC_TEST

The Computerized Adaptive Testing system of the Functional Assessment of Stroke comprises 58 items. The items were selected from four well-known physical function measures for patients with stroke: 26 items from the Fugl-Meyer Assessment-Upper limb, 11 items from the Fugl-Meyer Assessment-Lower limb, 12 items from the Postural Assessment Scale for Stroke Patients, and 9 items from the Barthel Index. These items evaluate motor control, postural control, and activity of daily living functions in patients with stroke. Results are automatically reported as Rasch scores (i.e., the minimum and maximum values are negative and positive infinity, respectively). A higher score indicates greater physical functions.

The Barthel Index

Intervention Type: DIAGNOSTIC_TEST

The Barthel Index has 10 items, and the total score ranges from 0 to 100. Higher score indicates less disability on activity of daily living functions.

The National Institutes of Health Stroke Scale

Intervention Type: DIAGNOSTIC_TEST

The National Institutes of Health Stroke Scale comprises 11 items and was used to monitor the severity in the patients with stroke. The total score ranges from 0 to 42, with a higher score indicating greater severity. A National Institutes of Health Stroke Scale score of 1-5 indicates mild severity; 6-14, mild to moderate severity; 15-24, severe severity; and equal to or greater than 25, very severe severity.

Interventions

The Computerized Adaptive Testing system of the Functional Assessment of Stroke

The Computerized Adaptive Testing system of the Functional Assessment of Stroke comprises 58 items. The items were selected from four well-known physical function measures for patients with stroke: 26 items from the Fugl-Meyer Assessment-Upper limb, 11 items from the Fugl-Meyer Assessment-Lower limb, 12 items from the Postural Assessment Scale for Stroke Patients, and 9 items from the Barthel Index. These items evaluate motor control, postural control, and activity of daily living functions in patients with stroke. Results are automatically reported as Rasch scores (i.e., the minimum and maximum values are negative and positive infinity, respectively). A higher score indicates greater physical functions.

Intervention Type: DIAGNOSTIC_TEST

The Barthel Index

The Barthel Index has 10 items, and the total score ranges from 0 to 100. Higher score indicates less disability on activity of daily living functions.

Intervention Type: DIAGNOSTIC_TEST

The National Institutes of Health Stroke Scale

The National Institutes of Health Stroke Scale comprises 11 items and was used to monitor the severity in the patients with stroke. The total score ranges from 0 to 42, with a higher score indicating greater severity. A National Institutes of Health Stroke Scale score of 1-5 indicates mild severity; 6-14, mild to moderate severity; 15-24, severe severity; and equal to or greater than 25, very severe severity.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Cerebral hemorrhage or cerebral infarction.
• Age ≥ 20 years.
• Stroke onset ≥ 6 months (first and recurrent stroke included).

• Cerebral hemorrhage or cerebral infarction.
• Age ≥ 20 years.
• Stroke onset < 3 months (first and recurrent stroke included).

Exclusion Criteria

• Patients' diagnosis is not stroke.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Hualien City, Hualien County, Taiwan

Countries

Taiwan

Other Identifiers

IRB110-263-B

Identifier Type: -

Identifier Source: org_study_id