Multidimensional Recovery Patterns and Prognostic Factors After Stroke

NCT06553755 | Active Not Recruiting

• 1 other identifier: N202406014
• Study Type: observational
• Target: 1,270
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Stroke

Keywords

functional status; prognosis; recovery; social participation; stroke subtypes

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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.

  From discharged from acute care up to 1 year

Secondary Outcomes (3)

• Barthel Index (BI)

  From discharged from acute care up to 1 year

• Modified Rankin Scale (mRS)

  From discharged from acute care up to 1 year

• The Center for Epidemiologic Studies Depression Scale (CES-D)

  From discharged from acute care up to 1 year

Other Outcomes (3)

• National Institutes of Health Stroke scale (NIHSS)

  From discharged from acute care up to 1 year

• Personal factors

  From discharged from acute care up to 1 year

• Environmental factors

  From discharged from acute care up to 1 year

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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).

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 14, 2024
• Study Start: August 12, 2024
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

TW (1)