StrokeNCT05524818
Validations of the Computerized Adaptive Testing System of the Functional Assessment of Stroke
An observational study of Stroke, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Stroke
- What is being tested?
- the Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS)
- How many people
- 76 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Apr 2021to 21 Feb 2022
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons with stroke were recruited from the Department of Physical Medicine and Rehabilitation at a medical center in Taiwan using consecutive sampling.
Who may be able to join
- Cerebral hemorrhage or cerebral infarction.
- Age ≥ 20 years.
- Stroke onset ≥ 6 months (first and recurrent stroke included).
- Ability to follow 3-step verbal instructions.
- Cerebral hemorrhage or cerebral infarction.
- Age ≥ 20 years.
- Stroke onset < 3 months (first and recurrent stroke included).
- Ability to follow 3-step verbal instructions.
Who cannot join
- Cannot complete the Computerized Adaptive Testing System of the Functional Assessment of Stroke twice.
- Refuse to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City, Hualien County, 970
About this study
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
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- the Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: the Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS) | |
| 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. Receives: Diagnostic Test: the Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS)
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.
Measured: 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start14 Apr 2021
- Primary completion21 Feb 2022
- Study completion21 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524818
- Sponsor's protocol ID
- IRB109-176-B
- Status last verified
- Aug 2022
- First submitted
- 30 Aug 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05524818
- Acronym / sponsor ID
- IRB109-176-B
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 21 Feb 2022 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test-retest reliability group | – | Diagnostic Test: the Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS)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. |
| Responsiveness group | – | Diagnostic Test: the Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS)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. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with stroke were recruited from the Department of Physical Medicine and Rehabilitation at a medical center in Taiwan using consecutive sampling.
Key inclusion criteria (8 listed)
- Cerebral hemorrhage or cerebral infarction.
- Age ≥ 20 years.
- Stroke onset ≥ 6 months (first and recurrent stroke included).
- Ability to follow 3-step verbal instructions.
- Cerebral hemorrhage or cerebral infarction.
Key exclusion criteria (2 listed)
- Cannot complete the Computerized Adaptive Testing System of the Functional Assessment of Stroke twice.
- Refuse to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS)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. | Diagnostic test | Responsiveness group, Test-retest reliability group |
Primary outcome
The Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS)
Time frame: 4 weeks.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS) (time frame: 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.