UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060240 |
|---|---|
| Receipt number | R000067789 |
| Scientific Title | Acute-phase sensorimotor deficits and unilateral spatial neglect after right-hemisphere stroke: an exploratory single-center observational study |
| Date of disclosure of the study information | 2025/12/30 |
| Last modified on | 2025/12/30 23:25:19 |
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Basic information
Public title
Acute-phase sensorimotor deficits and unilateral spatial neglect after right-hemisphere stroke
Acronym
Acute-phase sensorimotor deficits and unilateral spatial neglect after right-hemisphere stroke
Scientific Title
Acute-phase sensorimotor deficits and unilateral spatial neglect after right-hemisphere stroke: an exploratory single-center observational study
Scientific Title:Acronym
Acute-phase sensorimotor deficits and unilateral spatial neglect after right-hemisphere stroke: an exploratory single-center observational study
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare somatosensory and motor functions between patients with and without USN after acute right-hemisphere stroke.
Basic objectives2
Others
Basic objectives -Others
Explore whether somatosensory function or spatiotemporal attention-assessed with a PC-based system-differed between high- and low-motor subgroups of patients with USN.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
somatosensory (multimodal somatosensory impairment)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) a first-ever intracerebral hemorrhage or cerebral infarction in the right hemisphere; (2) age of 20 years or older; and (3) evaluation performed within 10 days after onset.
Key exclusion criteria
(1) prior history of stroke; (2) positive for coronavirus disease 2019; (3) presence of medical complications (e.g., pneumonia, urinary tract infection); (4) upper extremity orthopedic disorders; (5) inability to undergo evaluation due to infection control measures; and (6) inability to sit in a wheelchair.
Target sample size
122
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Shimodozono |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Rehabilitation and Physical Medicine
Zip code
890-8520
Address
8-35-1, Sakuragaoka, Kagoshima city, Kagoshima
TEL
099-275-5339
k8877352@kadai.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Hoei |
Organization
Kagoshima univercity hospital
Division name
Division of rehabilitation
Zip code
890-0075
Address
8-35-1, Sakuragaoka, Kagoshima city, Kagoshima
TEL
099-275-5111
Homepage URL
k8877352@kadai.jp
Sponsor or person
Institute
Kagoshima univercity
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Kagoshima univercity hospital
Address
8-35-1 sakuragaoka, kagoshima city
Tel
099-275-6624
crmc@m2.kufm.kagoshima-u.ac.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
| 2025 | Year | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 19 | 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
Analysis in progress
Management information
Registered date
| 2025 | Year | 12 | Month | 30 | Day |
Last modified on
| 2025 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067789
