UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060567 |
|---|---|
| Receipt number | R000068230 |
| Scientific Title | Heterogeneous Treatment Effects of Early High-Dose Rehabilitation in Acute Ischemic Stroke: Target Trial Emulation and Causal Forests |
| Date of disclosure of the study information | 2026/04/30 |
| Last modified on | 2026/03/25 09:27:58 |
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Basic information
Public title
Heterogeneous Treatment Effects of Early High-Dose Rehabilitation in Acute Ischemic Stroke: Target Trial Emulation and Causal Forests
Acronym
Heterogeneous Treatment Effects of Early High-Dose Rehabilitation in Acute Ischemic Stroke
Scientific Title
Heterogeneous Treatment Effects of Early High-Dose Rehabilitation in Acute Ischemic Stroke: Target Trial Emulation and Causal Forests
Scientific Title:Acronym
Heterogeneous Treatment Effects of Early High-Dose Rehabilitation in Acute Ischemic Stroke
Region
| Japan |
Condition
Condition
Ischemic Stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to operationally define and evaluate an "early high-dose" regimen (initiated <48 hours, duration 7 days) for acute ischemic stroke within the Target Trial Emulation (TTE) framework. In addition to estimating the average causal effect, we will use Causal Forests to identify Conditional Average Treatment Effects (CATE) tailored to patient characteristics.
Focusing on the clinically feasible first 7 days of hospitalization, we will compare dose designs to identify "high-benefit populations" (maximizing benefit while minimizing harm), thereby providing evidence to establish individualized rehabilitation strategies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Barthel Index at discharge
Key secondary outcomes
(1) Barthel Index (BI) shift categories (0~39, 40~59, 60~84, 85~100) at discharge (2) Achievement of functional independence, defined as a Barthel Index 60 (moderate independence or higher) at discharge (3) modified Rankin Scale (mRS) score at discharge.
Safety Outcomes:New-onset adverse events observed during the evaluation period (Day 1~7), including:In-hospital mortalityNew-onset aspiration pneumoniaTrauma/injury (e.g., falls)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligibility criteria were as follows: (1) ischemic stroke (ICD-10: I63*) identified in the DPC data as either the reason for admission or the principal diagnosis; (2) age >= 18 years; (3) pre-admission modified Rankin Scale (mRS) score <= 4; and (4) confirmed stay in a stroke care unit (SCU) on the day of admission (Day 1-SCU). Time zero was defined as the admission date (Day 1). Day 1-SCU was identified using a claims-based proxy definition: the first billing date of an SCU-related management fee in the DPC data coinciding with the admission date.
Key exclusion criteria
Exclusion criteria were: (1) cases suggestive of in-hospital onset; (2) cases with clear evidence of long-term care (LTC) residence prior to admission; and (3) cases with an explicit contraindication to rehabilitation immediately after admission (e.g., immediately after decompressive craniectomy, ventricular drainage/external ventricular drain [EVD] placement, initiation of extracorporeal membrane oxygenation [ECMO], or initiation of high-dose vasopressors).
Target sample size
40000
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Nagayama |
Organization
Kanagawa University of Human Services
Division name
Department of Occupational therapy, The School of Rehabilitation
Zip code
2388522
Address
1-10-1 Heiseicho, Yokosuka, Kanagawa, Japan
TEL
046-828-2724
nagayama-ktr@kuhs.ac.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Nagayama |
Organization
Kanagawa University of Human Services
Division name
Department of Occupational therapy, The School of Rehabilitation
Zip code
2388522
Address
1-10-1 Heiseicho, Yokosuka, Kanagawa, Japan
TEL
046-828-2724
Homepage URL
nagayama-ktr@kuhs.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics approval: Not applicable; ethics review was not required for this study.
Address
Ethics approval: Not applicable; ethics review was not required for this study.
Tel
Ethics approval: Not applicable; ethics review was
Ethics approval: Not applicable; ethics review was not required for this study.
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
三重大学
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study is, within a target trial emulation (TTE) framework, to operationally define an "early high-dose" rehabilitation regimen initiated within 48 hours and evaluated over the first 7 hospital days among patients with acute ischemic stroke, and to rigorously estimate its average causal effect. In addition, we will use causal forests to identify heterogeneity of treatment effects according to patient characteristics, expressed as conditional average treatment effects (CATE). We focus on a 7-day regimen from admission because it is clinically feasible to implement, and we will compare implementable dose designs and clarify a "high-benefit" subgroup from the perspective of maximizing benefit and minimizing harm, thereby generating evidence to inform personalized rehabilitation strategies.
Management information
Registered date
| 2026 | Year | 02 | Month | 03 | Day |
Last modified on
| 2026 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068230
