Clinical trial NCT05524818: Validations of the Computerized Adaptive Testing System of the Functional Assessment of Stroke
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Persons with stroke were recruited from the Department of Physical Medicine and Rehabilitation at a medical center in Taiwan using consecutive sampling.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS)
timeFrame: 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Hualien city
country: Taiwan
facility: Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
state: Hualien County
Study officials:
References: