UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059308 |
|---|---|
| Receipt number | R000067749 |
| Scientific Title | Estimating the Minimal Important Change of the Action Research Arm Test in Subacute Stroke Patients. |
| Date of disclosure of the study information | 2025/12/10 |
| Last modified on | 2025/11/24 08:38:23 |
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Basic information
Public title
Estimating of the Minimal Important Change of the Action Research Arm Test in Subacute Stroke Patients.
Acronym
Minimal Important Change of the Action Research Arm Test
Scientific Title
Estimating the Minimal Important Change of the Action Research Arm Test in Subacute Stroke Patients.
Scientific Title:Acronym
Minimal Important Change of the Action Research Arm Test in Subacute Stroke Patients.
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to estimate the Minimal Important Change (MIC) of the Action Research Arm Test (ARAT) in subacute stroke patients undergoing inpatient rehabilitation, in accordance with the COSMIN guidelines. By clarifying the MIC, this study seeks to add a patient- and clinician-meaningful perspective to the interpretation of ARAT scores, thereby providing a foundation for more appropriate treatment selection in subacute stroke rehabilitation
Basic objectives2
Others
Basic objectives -Others
The purpose of this study was to estimate the Minimal Important Change (MIC) of the Action Research Arm Test (ARAT) in patients with subacute stroke.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of the Action Research Arm Test
Global rating scale of change (Patient perspective)
Global rating scale of change (Therapist perspective)
Key secondary outcomes
Fugl-Meyer Assessment
Motor Activity Log
Functional Independence Measure
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Ptients with upper extremity paresis resulting stroke are included.
(1) age 20 years or older
(2) ability to maintain a sitting position
(3) absence of severe cognitive or higher brain dysfunction
(4) ability to undergo ARAT assessment.
Key exclusion criteria
Patients who score 55 or higher on the ARAT will be excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hikaru |
| Middle name | |
| Last name | Yamaoka |
Organization
Shonan-Keiiku Hospital
Division name
Department of rehabilitation
Zip code
252-0816
Address
4360, Endo, Fujisawa, Kanagawa, Japan
TEL
0466-48-0050
yamaoka.h.ot@gmail.com
Public contact
Name of contact person
| 1st name | Hikaru |
| Middle name | |
| Last name | Yamaoka |
Organization
Shonan-Keiiku Hospital
Division name
Department of rehabilitation
Zip code
252-0816
Address
4360, Endo, Fujisawa, Kanagawa, Japan
TEL
0466-48-0050
Homepage URL
yamaoka.h.ot@gmail.com
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shonan-Keiiku Hospital
Address
4360, Endo, Fujisawa, Kanagawa, Japan
Tel
0466-48-0050
yamaoka.h.ot@gmail.com
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
| 2025 | Year | 12 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Estimation of MIC: The Global Rating of Change (GROC) was used as an anchor. Based on the GROC scores, participants were classified into two groups: those with scores below 5 were defined as the no meaningful change group, and those with scores of 6 or higher were defined as the meaningful change group. Receiver Operating Characteristic (ROC) curve analysis was then conducted using ARAT scores in JMP to estimate the MIC.
Management information
Registered date
| 2025 | Year | 10 | Month | 06 | Day |
Last modified on
| 2025 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067749
