- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05524818
Validations of the Computerized Adaptive Testing System of the Functional Assessment of Stroke
Test-retest Reliability, Responsiveness, and Utility of the Computerized Adaptive Testing System of the Functional Assessment of Stroke in Patients With Stroke in Clinical Settings: A Pilot Study
Purposes: The aim of this study is to preliminarily validate the test-retest reliability, random measurement error, practice effect, and responsiveness of the the Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS) in real clinical settings.
Methods: Patients in both chronic (get stroke over 6 months) and sub-acute (get stroke less than 6 months) stages will be recruited. These patients will be classified into "test-retest reliability group" and "responsiveness group" to examine the test-retest reliability and responsiveness of the CAT-FAS, respectively. All participants will receive the administrations of CAT-FAS twice. For those in the test-retest reliability group, the administrations will be performed with a 4-week interval. For those in the responsiveness group, the administrations will be performed at admitting to the rehabilitation unit and before they are discharged.
Study Overview
Status
Conditions
Detailed Description
Participants Persons with stroke were recruited from the Department of Physical Medicine and Rehabilitation at a medical center in Taiwan using consecutive sampling. The study was approved by the local institutional review board, and all of the participants provided informed consent. Because the targeted populations for examining the test-retest reliability and responsiveness were different, the inclusion and exclusion criteria are listed separately below.
Test-retest reliability Outpatients with chronic stroke were recruited to examine the test-retest reliability. The participants met the following criteria: (1) diagnosis of cerebral hemorrhage or cerebral infarction, (2) age ≥ 20 years, (3) stroke onset ≥ 6 months (first and recurrent stroke included), and (4) ability to follow 3-step verbal instructions.
Responsiveness Inpatients undergoing rehabilitation with subacute stroke were recruited to examine the responsiveness. The participants met the following criteria: (1) diagnosis of cerebral hemorrhage or cerebral infarction, (2) age ≥ 20 years, (3) stroke onset < 3 months (first and recurrent stroke included), and (4) ability to follow 3-step verbal instructions.
Procedures Test-retest design was adopted. The data were collected by an experienced and well-trained occupational therapist, and included demographic characteristics, the National Institutes of Health Stroke Scale (NIHSS), and the the Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS). The demographic and clinical characteristics were gathered from medical records. The NIHSS and the CAT-FAS were administered by the therapist twice, at different intervals depending on the groups. For the participants in the test-retest reliability group, the two assessments were performed at an one-month interval. For participants in the responsiveness group, the two assessments were administered at study commencement and hospital discharge.
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
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria for test-retest reliability group:
- Cerebral hemorrhage or cerebral infarction.
- Age ≥ 20 years.
- Stroke onset ≥ 6 months (first and recurrent stroke included).
- Ability to follow 3-step verbal instructions.
Inclusion criteria for responsiveness group:
- Cerebral hemorrhage or cerebral infarction.
- Age ≥ 20 years.
- Stroke onset < 3 months (first and recurrent stroke included).
- Ability to follow 3-step verbal instructions.
Exclusion criteria for both group:
- Cannot complete the Computerized Adaptive Testing System of the Functional Assessment of Stroke twice.
- Refuse to provide informed consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Test-retest reliability group
All the participants received conventional rehabilitation (e.g., occupational therapy, physical therapy, or speech therapy) or other interventions (e.g., acupuncture) as usual during the research period.
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The CAT-FAS 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.
The CAT-FAS assesses all these functions simultaneously.
Results are automatically reported as Rasch scores.
A higher score indicates greater physical functions.
In the previous study, results indicated that the CAT-FAS had sufficient efficiency (< 10 items on average), reliability (Rasch reliability ≥ 0.88), concurrent validity (Pearson r ≥ 0.91), and responsiveness (SRM ≥ 0.65) in persons with stroke.
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Responsiveness group
All the participants received conventional rehabilitation (e.g., occupational therapy, physical therapy, or speech therapy) or other interventions (e.g., acupuncture) as usual during the research period.
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The CAT-FAS 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.
The CAT-FAS assesses all these functions simultaneously.
Results are automatically reported as Rasch scores.
A higher score indicates greater physical functions.
In the previous study, results indicated that the CAT-FAS had sufficient efficiency (< 10 items on average), reliability (Rasch reliability ≥ 0.88), concurrent validity (Pearson r ≥ 0.91), and responsiveness (SRM ≥ 0.65) in persons with stroke.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS)
Time Frame: 4 weeks.
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The Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS) 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.
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.
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4 weeks.
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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 (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB109-176-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
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