UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059096 |
|---|---|
| Receipt number | R000067601 |
| Scientific Title | Investigation of Dual-Task Interference Patterns in Mild Stroke Patients Using Cluster Analysis |
| Date of disclosure of the study information | 2025/09/16 |
| Last modified on | 2025/09/16 13:18:53 |
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Basic information
Public title
Evaluation Study of Motor and Cognitive Dual-Task Effects in Mild Stroke Patients
Acronym
Mild Stroke Dual-Task Study
Scientific Title
Investigation of Dual-Task Interference Patterns in Mild Stroke Patients Using Cluster Analysis
Scientific Title:Acronym
Mild Stroke Dual-Task Interference Analysis Study
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To classify patients with mild stroke based on the levels of motor dual-task interference and cognitive dual-task interference, and to clarify the clinical characteristics of each subgroup.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10-meter comfortable walking speed under single-task and dual-task conditions
Key secondary outcomes
Correct response rate
Fugl-Meyer Assessment for Lower Extremity
Berg Balance Scale
Mini-Mental State Examination
Trail Making Test
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
| 60 | years-old | < |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) the ability to walk independently or under supervision on level indoor surfaces
(2) a score of 21 on the lower extremity subscale of the Fugl-Meyer Assessment
Key exclusion criteria
(1) difficulty understanding tasks due to aphasia or severe attentional deficits
(2) severe paralysis or orthopedic conditions that significantly limited walking ability
(3) severe visual or hearing impairments
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | Yusuke Harada |
| Last name | Harada |
Organization
Reiwa Rehabilitation Hospital, Chinseikai Medical Corporation
Division name
Department of Rehabilitation Medicine
Zip code
260-0026
Address
4-4 Chibaminato, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-242-0180
t.sawataishi.0528@gmail.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | Yusuke Harada |
| Last name | Harada |
Organization
Reiwa Rehabilitation Hospital, Chinseikai Medical Corporation
Division name
Department of Rehabilitation Medicine
Zip code
260-0026
Address
4-4 Chibaminato, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-242-0180
Homepage URL
harada1111.0917@gmail.com
Sponsor or person
Institute
Reiwa Rehabilitation Hospital, Chinseikai Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Reiwa Rehabilitation Hospital, Chinseikai Medical Corporation
Address
4-4 Chibaminato, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
043-242-0180
harada1111.0917@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 | 09 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Between June 1, 2023, and May 15, 2025, individuals with mild stroke who were admitted to a convalescent rehabilitation hospital were enrolled.
Management information
Registered date
| 2025 | Year | 09 | Month | 16 | Day |
Last modified on
| 2025 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067601
