StrokeNCT05530525
Psychometric Evaluation of Commonly Used Measures in 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 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. 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, The Barthel Index and The National Institutes of Health Stroke Scale
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2022to 31 Dec 2023
- 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: All the data was from the medical record (from 2018/6/1 to 2021/6/30) from the Department of Physical Medicine and Rehabilitation at a medical center in Taiwan.
Who may be able to join
None listed.
Who cannot join
- Patients' diagnosis is not stroke.
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: 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.
Read the 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).
- Conditions
- Stroke
- Being tested
- The Computerized Adaptive Testing system of the Functional Assessment of Stroke, The Barthel Index, The National Institutes of Health Stroke Scale
- 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 StrokeDiagnostic test
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 IndexDiagnostic test
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 ScaleDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: The Computerized Adaptive Testing system of the Functional Assessment of Stroke; Diagnostic Test: The Barthel Index; Diagnostic Test: The National Institutes of Health Stroke Scale |
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
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.
Measured: The repeated assessments were performed at an one-month interval.
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.
Measured: The repeated assessments were performed at an one-month interval.
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.
Measured: The repeated assessments were performed at an one-month interval.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Apr 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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
- Retrospective
- Enrolment
- 50 participants (actual)
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
- NCT05530525
- Sponsor's protocol ID
- IRB110-263-B
- Status last verified
- Aug 2022
- First submitted
- 31 Aug 2022
- Last updated
- 19 Sep 2025
- 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 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Evaluation of Commonly Used Measures in Patients With Stroke Using Medical Record Review
- ClinicalTrials.gov ID
- NCT05530525
- Acronym / sponsor ID
- IRB110-263-B
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test-retest reliability and responsiveness group (All of the data was collected from medical record) | – | Diagnostic Test: The Computerized Adaptive Testing system of the Functional Assessment of Stroke, Diagnostic Test: The Barthel Index, Diagnostic Test: The National Institutes of Health Stroke ScaleAll the participants received conventional rehabilitation (e.g., occupational therapy, physical therapy, or speech therapy) or other interventions (e.g., acupuncture). |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the data was from the medical record (from 2018/6/1 to 2021/6/30) from the Department of Physical Medicine and Rehabilitation at a medical center in Taiwan.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients' diagnosis is not stroke.
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 StrokeThe 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. | Diagnostic test | Test-retest reliability and responsiveness group (All of the data was collected from medical record) |
| The Barthel IndexThe 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. | Diagnostic test | Test-retest reliability and responsiveness group (All of the data was collected from medical record) |
| The National Institutes of Health Stroke ScaleThe 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. | Diagnostic test | Test-retest reliability and responsiveness group (All of the data was collected from medical record) |
Primary outcome
The computerized adaptive testing system of the functional assessment of stroke
Time frame: The repeated assessments were performed at an one-month interval.
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
Time frame: The repeated assessments were performed at an one-month interval.
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
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.
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 19 Sep 2025.
- 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 0 inclusion and 1 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 19 Sep 2025. 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 (time frame: The repeated assessments were performed at an one-month interval.). The study lists 3 primary outcomes in all. 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 19 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.