UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058259 |
|---|---|
| Receipt number | R000066598 |
| Scientific Title | Validity Assessment of the Associated Reaction Assessment Scale (ARAS) in Patients with Post-stroke Hemiparesis |
| Date of disclosure of the study information | 2025/06/24 |
| Last modified on | 2025/06/24 00:04:58 |
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Basic information
Public title
A study on the assessment method for associated reactions in patients with post-stroke hemiparesis
Acronym
ARAS study
Scientific Title
Validity Assessment of the Associated Reaction Assessment Scale (ARAS) in Patients with Post-stroke Hemiparesis
Scientific Title:Acronym
Development of associated reaction assessment scale for patients with post-stroke hemiparesis
Region
| Japan |
Condition
Condition
Post-stroke hemiparesis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the relative reliability and construct validity of the Associated Reaction Assessment Scale (ARAS) developed for patients with post-stroke hemiparesis. Multiple regression analysis will be used to examine the relationships between ARAS scores and established clinical measures, including motor function (Fugl-Meyer Assessment: FMA), spasticity (Modified Ashworth Scale: MAS), and neurological severity (National Institutes of Health Stroke Scale: NIHSS), to determine whether ARAS is a clinically useful tool for objective and practical assessment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scores of the Associated Reaction Assessment Scale (ARAS)
Correlation with motor function (Fugl-Meyer Assessment)
Correlation with spasticity (Modified Ashworth Scale)
Correlation with neurological severity (NIH Stroke Scale)
These relationships will be analyzed using multiple regression analysis.
Key secondary outcomes
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Presence of post-stroke hemiplegia
At least one year had elapsed since stroke onset
Age over 40 years
Graded between 2 and 5 on the modified Rankin Scale (mRS)
Key exclusion criteria
Severe limitation of range of motion of joints
Patients experiencing difficulties in comprehending task instructions
Individuals with reduced arousal levels
Those diagnosed with ataxia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Jikko |
Organization
Van-Vert Long-Term Care Health Facility, Juyama Medical Corporation
Division name
Corporate Rehabilitation Department
Zip code
5780941
Address
4-2-8 Iwadacho, Higashi-Osaka City, Osaka Prefecture
TEL
0729616888
jicchi.08p021@gmail.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Jikko |
Organization
Van-Vert Long-Term Care Health Facility, Juyama Medical Corporation
Division name
Corporate Rehabilitation Department
Zip code
5780941
Address
4-2-8 Iwadacho, Higashi-Osaka City, Osaka Prefecture
TEL
0729616888
Homepage URL
jicchi.08p021@gmail.com
Sponsor or person
Institute
Van-Vert Long-Term Care Health Facility, Juyama Medical Corporation
Graduate School of Medicine, Juntendo University
Institute
Department
Personal name
Funding Source
Organization
No external funding was provided. The study was self-supported.
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
Van-Vert Long-Term Care Health Facility, Juyama Medical Corporation
Address
4-2-8 Iwadacho, Higashi-Osaka City, Osaka Prefecture
Tel
0729616888
jicchi.08p021@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 | 06 | Month | 24 | 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 | 07 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2028 | 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 an observational study aimed at evaluating the construct validity and relative reliability of the Associated Reaction Assessment Scale (ARAS), a newly developed assessment tool. The participants are patients with post-stroke hemiparesis. The ARAS assesses associated reactions in the paretic upper limb during a maximal voluntary movement of the non-paretic lower limb in the supine position, using a 5-point ordinal scale. Relationships between ARAS scores and clinical measures such as the Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), and NIH Stroke Scale (NIHSS) will be examined using multiple regression analysis.
Management information
Registered date
| 2025 | Year | 06 | Month | 24 | Day |
Last modified on
| 2025 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066598
