Psychometric Evaluation of Commonly Used Measures in Stroke
Psychometric Evaluation of Commonly Used Measures in Patients With Stroke Using Medical Record Review
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.
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hualien County
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Hualien City, Hualien County, Taiwan, 970
- Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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).
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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 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 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The computerized adaptive testing system of the functional assessment of stroke
Time Frame: The repeated assessments were performed at an one-month interval.
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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.
|
|
The Barthel Index
Time Frame: The repeated assessments were performed at an one-month interval.
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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.
|
|
The National Institutes of Health Stroke Scale
Time Frame: The repeated assessments were performed at an one-month interval.
|
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.
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The repeated assessments were performed at an one-month interval.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB110-263-B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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