UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061151 |
|---|---|
| Receipt number | R000069976 |
| Scientific Title | A prospective observational registry study in a convalescent rehabilitation ward to estimate minimal important change (MIC) anchored to a Global Rating Scale and to identify recovery trajectory classes in stroke patients |
| Date of disclosure of the study information | 2026/04/20 |
| Last modified on | 2026/04/03 13:31:12 |
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Basic information
Public title
Observational study linking patient-perceived change with routine rehabilitation outcomes in convalescent stroke patients
Acronym
STRoKe-REC
Scientific Title
A prospective observational registry study in a convalescent rehabilitation ward to estimate minimal important change (MIC) anchored to a Global Rating Scale and to identify recovery trajectory classes in stroke patients
Scientific Title:Acronym
STRoKe-REC
Region
| Japan |
Condition
Condition
Stroke(ischemic stroke and intracerebral hemorrhage), convalescent phase
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate minimal important change (MIC) in routinely collected rehabilitation outcomes using a Global Rating Scale as an anchor, and to identify distinct recovery trajectory classes from monthly longitudinal data during inpatient convalescent rehabilitation, examining clinical characteristics and therapy-related factors (e.g., therapy time) associated with each class.
Basic objectives2
Others
Basic objectives -Others
Estimation of MIC and identification of recovery trajectory classes using observational registry data
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Global Rating Scale (7-point): patient-rated overall change at discharge compared with admission (time point: discharge)
Key secondary outcomes
BBS, gait speed, FAC, FMA-UE/LE, ARAT, motor/cognitive FIM, MMSE, NIHSS, BRS, knee extensor strength, grip strength, mRS (time points: admission, monthly, discharge). Recovery trajectory classes (latent class growth analysis) and MIC estimates anchored to GRS.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed with ischemic stroke or intracerebral hemorrhage and admitted to a convalescent rehabilitation ward after acute care; 2) Routinely assessed outcomes defined in this study are available from admission through discharge; 3) Not opted out.
Key exclusion criteria
1) Primary assessments cannot be obtained due to medical reasons (e.g., severe complications, clinical deterioration); 2) Opt-out declared during the study period.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Kitaji |
Organization
Tokyo General Hospital
Division name
Department of Rehabilitation
Zip code
165-8906
Address
Egota 3-15-2, Nakano-ku, Tokyo
TEL
03-3387-5421
yu.kitaji@mt.strins.or.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Kitaji |
Organization
Tokyo General Hospital
Division name
Department of Rehabilitation
Zip code
165-8906
Address
Egota 3-15-2, Nakano-ku, Tokyo
TEL
03-3387-5421
Homepage URL
yu.kitaji@mt.strins.or.jp
Sponsor or person
Institute
Tokyo General Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funded (institutional resources)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo General Hospital
Address
Egota 3-15-2, Nakano-ku, Tokyo
Tel
03-3387-5421
yu.kitaji@mt.strins.or.jp
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 20 | 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 | 26 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective observational cohort registry. Consecutive stroke patients admitted to a convalescent rehabilitation ward between [May/2026] and [March/2029] will be included. Routine outcomes are collected at admission, monthly during hospitalization, and at discharge. A 7-point Global Rating Scale at discharge will be used as an anchor to estimate MIC for each outcome. Recovery trajectory classes will be identified using latent class growth analysis, and associations with baseline characteristics and therapy time will be examined. An opt-out approach will be used.
Management information
Registered date
| 2026 | Year | 04 | Month | 03 | Day |
Last modified on
| 2026 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069976
