Psychometric Evaluation of Commonly Used Measures in Stroke

Stroke Clinical Trial

Official title:

Psychometric Evaluation of Commonly Used Measures in Patients With Stroke Using Medical Record Review

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05530525
• Other study ID #: IRB110-263-B
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Buddhist Tzu Chi General Hospital
• Contact: Po-Ting Chen
• Phone: (+886) 03-8561825
• Email: bordenpooh103[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

Inclusion criteria for test-retest reliability group (Chronic stroke patients' medical

record was reviewed to examine the test-retest reliability) :

• Cerebral hemorrhage or cerebral infarction.
• Age = 20 years.
• Stroke onset = 6 months (first and recurrent stroke included). Inclusion criteria for responsiveness group (Subacute stroke patients' medical record was

reviewed to examine the responsiveness):

• Cerebral hemorrhage or cerebral infarction.
• Age = 20 years.
• Stroke onset < 3 months (first and recurrent stroke included). Exclusion criteria
• Patients' diagnosis is not stroke.

Related Conditions & MeSH terms

• Stroke

Intervention

Diagnostic Test:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	Hualien City	Hualien County

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The repeated assessments were performed at an one-month interval.
Primary	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.	The repeated assessments were performed at an one-month interval.
Primary	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.	The repeated assessments were performed at an one-month interval.