StrokeNCT06553755
Multidimensional Recovery Patterns and Prognostic Factors After Stroke
An observational study of Stroke, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
This study aims to compare the 1-year recovery trajectories of multidimensional functional recovery among stroke survivors after discharge from hospital care. To address this purpose, a retrospective analysis will be conducted using clinical data from two independent cohorts derived from previously published… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- How many people
- 1,270 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Aug 2024to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: The retrospective study is based on the clinical data of two independent cohorts from previously published prospective, observational studies. The ethics committee approved these studies at the Taipei Medical University. Both cohorts recruited stroke patients at three hospitals (Taipei Medical University Hospital, Wan Fang Hospital, Shuang Ho Hospital) between January 2016 and September 2018, collecting functional outcomes and person-environment variables since discharged from hospital to 12-month post-discharge follow-up.
Who may be able to join
- Stroke survivors
- aged 20 years or older;
- were diagnosed with a stroke confirmed by physicians;
- were assessed at least one of the outcomes of interest, including participation (Participation Measure-3 Domains, 4 Dimensions, PM-3D4D), activity limitations (Activity Measure for Post-Acute Care short forms, AM-PAC), HRQoL (EuroQol-5D-3L, EQ-5D-3L), and cognitive impairments (Montreal Cognitive Assessment, MoCA).
- Exclusion Criteria: Stroke survivors who missed all follow-up assessments.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unraveling the Multidimensional Functional Recovery Patterns and Prognostic Factors in Post-Discharged Stroke Survivors: A Retrospective Study
This study aims to compare the 1-year recovery trajectories of multidimensional functional recovery among stroke survivors after discharge from hospital care.
To address this purpose, a retrospective analysis will be conducted using clinical data from two independent cohorts derived from previously published prospective observational studies. The study will conduct generalized estimating equations and mixed-effects regression models to assess differences in recovery trends among stroke subgroups.
The findings will provide detailed profiles of longitudinal changes in functional outcomes one year after discharge from hospital care. These results will clarify how stroke subtypes influence long-term functional outcomes and will guide the development of targeted interventions.
Read the detailed description
Different stroke types have unique pathophysiological mechanisms that likely affect various recovery outcomes. Understanding stroke-subtype-specific functional recovery and outcomes is crucial for effective rehabilitation and discharge planning. However, current evidence does not fully reveal how functional outcomes differ by stroke subtype, leaving gaps in our understanding of how these differences impact post-stroke recovery. Identifying the specific recovery patterns and prognostic factors associated with each stroke subtype can enhance personalized rehabilitation strategies and improve patient care.
To address this purpose, a retrospective study utilizing clinical data from two independent cohorts recruited from collaborative hospitals in Northern Taiwan between 2016 and 2018 will be implemented. The study will employ several outcome measures, including the Participation Measure-3 Domains, 4 Dimensions (PM-3D4D), the Activity Measure for Post-Acute Care (AM-PAC), the modified Rankin Scale (mRS) and other standardized assessment tools. Participants will be assessed from hospital discharge until 12-month follow-up. Data analysis will use generalized estimating equations and mixed-effects regression models to evaluate differences in recovery trends among stroke subgroups.
The findings will offer comprehensive insights into the progression of various functional outcomes of specific stroke subtypes over the course of one year following discharge. The study will also identify factors associated with long-term functional outcomes and investigate how those factors impact the trend of functional recovery. These results will demonstrate the association of stroke subtypes and long-term functional outcomes, facilitating the development of targeted interventions.
- Conditions
- Stroke
- Keywords
- functional status, prognosis, recovery, social participation, stroke subtypes
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation Measure-3 Domains, 4 Dimensions (PM-3D4D)
The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community. Respondents are asked to rate each item on four dimensions: (1) 'Diversity of participation' (yes [1] vs. no [0]); (2) 'Frequency'(5- and 7-point scales, from "never" to "everyday or almost everyday"); (3) 'Desire for change' (yes [1] vs. no[0]); and (4) 'Perceived difficulty' (4-point scale, from "very difficult" [1] to "not difficult at all" [4]). Each dimensional score of the PM-3D4D can be separately summed for each domain. Psychometric properties of the PM-3D4D were established in rehabilitation populations.
Measured: From discharged from acute care up to 1 year
Activity Measure for Post-Acute Care (AM-PAC)
The Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores range 18-72, 15-60, 19-76 points respectively among three subscales. Higher score indicates better function of the specific domain. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.
Measured: From discharged from acute care up to 1 year
Euro-QoL-5-Dimension-3 Level (EQ-5D-3L)
The Euro-QoL-5-Dimension-3 Level (EQ-5D-3L) is used to assess participant's health related quality of life which consist of 5 ordinal scale items and 1 item with visual analog scale. Ordinal scales are rated 0-3 points with higher score indicating the pooer health-related quality of life. visual analog scale are rated by respondents reporting perceived health status with a grade ranging from 0 to 100 with higher score indicating the better health status).
Measured: From discharged from acute care up to 1 year
Montreal Cognitive Assessment (MoCA)
Montreal Cognitive Assessment (MoCA) is a clinician-reported measure consisting of cognition domains such as: visuospatial skills, executive functions, attention, concentration, calculation, language, abstraction, memory, and orientation. The summary score ranges from 0-30 points with higher scores indicating better cognitive function.
Measured: From discharged from acute care up to 1 year
Secondary outcomes (3)
Barthel Index (BI)
Barthel Index (BI) is a commonly used measurement indicating independence level of self-care, with higher scores indicating a better self-care independence.
Measured: From discharged from acute care up to 1 year
Modified Rankin Scale (mRS)
The modified Rankin Scale (mRS) is designed to measure functional status after a stroke. Each participant is rated 0-6 point on an ordinal scale with lower score indicating greater functional status after stroke.
Measured: From discharged from acute care up to 1 year
The Center for Epidemiologic Studies Depression Scale (CES-D)
The Center for Epidemiologic Studies Depression Scale (CES-D) is a self-reported outcome measure of depressive symptoms, with higher scores indicating the presence of more severe symptom (range: 0-60).
Measured: From discharged from acute care up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start12 Aug 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
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.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- 1,270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng-Hang Chang, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553755
- Sponsor's protocol ID
- N202406014
- Status last verified
- Mar 2025
- First submitted
- 12 Aug 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unraveling the Multidimensional Functional Recovery Patterns and Prognostic Factors in Post-Discharged Stroke Survivors: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06553755
- Acronym / sponsor ID
- N202406014
- Conditions
- Stroke
- Keywords
- functional status, prognosis, recovery, social participation, stroke subtypes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,270 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 14 Aug 2024 (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.
This study aims to compare the 1-year recovery trajectories of multidimensional functional recovery among stroke survivors after discharge from hospital care.
To address this purpose, a retrospective analysis will be conducted using clinical data from two independent cohorts derived from previously published prospective observational studies. The study will conduct generalized estimating equations and mixed-effects regression models to assess differences in recovery trends among stroke subgroups.
The findings will provide detailed profiles of longitudinal changes in functional outcomes one year after discharge from hospital care. These results will clarify how stroke subtypes influence long-term functional outcomes and will guide the development of targeted interventions.
Detailed description
Different stroke types have unique pathophysiological mechanisms that likely affect various recovery outcomes. Understanding stroke-subtype-specific functional recovery and outcomes is crucial for effective rehabilitation and discharge planning. However, current evidence does not fully reveal how functional outcomes differ by stroke subtype, leaving gaps in our understanding of how these differences impact post-stroke recovery. Identifying the specific recovery patterns and prognostic factors associated with each stroke subtype can enhance personalized rehabilitation strategies and improve patient care.
To address this purpose, a retrospective study utilizing clinical data from two independent cohorts recruited from collaborative hospitals in Northern Taiwan between 2016 and 2018 will be implemented. The study will employ several outcome measures, including the Participation Measure-3 Domains, 4 Dimensions (PM-3D4D), the Activity Measure for Post-Acute Care (AM-PAC), the modified Rankin Scale (mRS) and other standardized assessment tools. Participants will be assessed from hospital discharge until 12-month follow-up. Data analysis will use generalized estimating equations and mixed-effects regression models to evaluate differences in recovery trends among stroke subgroups.
The findings will offer comprehensive insights into the progression of various functional outcomes of specific stroke subtypes over the course of one year following discharge. The study will also identify factors associated with long-term functional outcomes and investigate how those factors impact the trend of functional recovery. These results will demonstrate the association of stroke subtypes and long-term functional outcomes, facilitating the development of targeted interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The retrospective study is based on the clinical data of two independent cohorts from previously published prospective, observational studies. The ethics committee approved these studies at the Taipei Medical University. Both cohorts recruited stroke patients at three hospitals (Taipei Medical University Hospital, Wan Fang Hospital, Shuang Ho Hospital) between January 2016 and September 2018, collecting functional outcomes and person-environment variables since discharged from hospital to 12-month post-discharge follow-up.
Key inclusion criteria (5 listed)
- Stroke survivors
- aged 20 years or older;
- were diagnosed with a stroke confirmed by physicians;
- were assessed at least one of the outcomes of interest, including participation (Participation Measure-3 Domains, 4 Dimensions, PM-3D4D), activity limitations (Activity Measure for Post-Acute Care short forms, AM-PAC), HRQoL (EuroQol-5D-3L, EQ-5D-3L), and cognitive impairments (Montreal Cognitive Assessment, MoCA).
- Exclusion Criteria: Stroke survivors who missed all follow-up assessments.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participation Measure-3 Domains, 4 Dimensions (PM-3D4D)
Time frame: From discharged from acute care up to 1 year
The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community. Respondents are asked to rate each item on four dimensions: (1) 'Diversity of participation' (yes [1] vs. no [0]); (2) 'Frequency'(5- and 7-point scales, from "never" to "everyday or almost everyday"); (3) 'Desire for change' (yes [1] vs. no[0]); and (4) 'Perceived difficulty' (4-point scale, from "very difficult" [1] to "not difficult at all" [4]). Each dimensional score of the PM-3D4D can be separately summed for each domain. Psychometric properties of the PM-3D4D were established in rehabilitation populations.
Activity Measure for Post-Acute Care (AM-PAC)
Time frame: From discharged from acute care up to 1 year
The Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores range 18-72, 15-60, 19-76 points respectively among three subscales. Higher score indicates better function of the specific domain. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.
Euro-QoL-5-Dimension-3 Level (EQ-5D-3L)
Time frame: From discharged from acute care up to 1 year
The Euro-QoL-5-Dimension-3 Level (EQ-5D-3L) is used to assess participant's health related quality of life which consist of 5 ordinal scale items and 1 item with visual analog scale. Ordinal scales are rated 0-3 points with higher score indicating the pooer health-related quality of life. visual analog scale are rated by respondents reporting perceived health status with a grade ranging from 0 to 100 with higher score indicating the better health status).
Montreal Cognitive Assessment (MoCA)
Time frame: From discharged from acute care up to 1 year
Montreal Cognitive Assessment (MoCA) is a clinician-reported measure consisting of cognition domains such as: visuospatial skills, executive functions, attention, concentration, calculation, language, abstraction, memory, and orientation. The summary score ranges from 0-30 points with higher scores indicating better cognitive function.
3 secondary outcomes
Barthel Index (BI)
Time frame: From discharged from acute care up to 1 year
Modified Rankin Scale (mRS)
Time frame: From discharged from acute care up to 1 year
The Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: From discharged from acute care up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
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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 Taipei Medical University 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 5 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 24 Mar 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?
This study is still under way. Results are not available in the source record yet.
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?
Participation Measure-3 Domains, 4 Dimensions (PM-3D4D) (time frame: From discharged from acute care up to 1 year). The study lists 4 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 24 Mar 2025.