UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057056 |
|---|---|
| Receipt number | R000064963 |
| Scientific Title | Immediate effects of verbal interaction on disorders of consciousness after stroke ~Comparison of verbal interaction in enjoyment of leisure activities with verbal interaction in general~ |
| Date of disclosure of the study information | 2025/02/18 |
| Last modified on | 2026/02/17 11:01:14 |
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Basic information
Public title
Immediate effect of communication on disorders of consciousness after stroke
~Comparison of communication in enjoyment of leisure activities with general communication~
Acronym
Immediate effects of communication recalling enjoyment of leisure activities on disorders of consciousness after stroke
Scientific Title
Immediate effects of verbal interaction on disorders of consciousness after stroke
~Comparison of verbal interaction in enjoyment of leisure activities with verbal interaction in general~
Scientific Title:Acronym
Immediate effects of verbal interaction in enjoyment of leisure activities on disorders of consciousness after stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine whether linguistic interactions that recall the enjoyment of leisure activities can immediately improve disorders of consciousness after a stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese version of the coma recovery scale-revised
Key secondary outcomes
Functional Independence Measure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
One session of mobilization training will be conducted as occupational therapy. The experimental group will engage in linguistic interactions recalling the enjoyment of leisure activities. The main outcomes will be examined before and after occupational therapy is implemented.
Interventions/Control_2
One session of mobilization training will be conducted as occupational therapy. The control group will engage in general linguistic interactions without recalling enjoyment of leisure activities. The main outcomes will be examined before and after occupational therapy is implemented.
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
Being a stroke patient.
Subjects with a confirmed diagnosis of impaired disorders of consciousness.
Subjects with a prescription for occupational therapy.
Key exclusion criteria
Subjects with serious complications.
Subjects who have not been authorized for mobilization training by their attending physician.
Subjects with speech and comprehension impairments due to aphasia.
Subjects taking sedatives, antipsychotics, or sleeping pills.
Subjects with abnormal blood test results(C-reactive protein is 0.14 mg/dL or higher, Calcium is 10.1 mg/dL or higher, Sodium is not between 138 and 145 mmol/L)
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | DAICHI |
| Middle name | |
| Last name | NISHIMURA |
Organization
Hakodate Medical Association Nursing and Rehabilitation Academy
Division name
Biomedical Science and Engineering Research Center
Zip code
040-0081
Address
5-16 Taya-cho, Hakodate-shi, Hokkaido
TEL
0138-43-8282
nishimura@hma-ns-reha.ac.jp
Public contact
Name of contact person
| 1st name | DAICHI |
| Middle name | |
| Last name | NISHIMURA |
Organization
Hakodate Medical Association Nursing and Rehabilitation Academy
Division name
Biomedical Science and Engineering Research Center
Zip code
040-0081
Address
5-16 Taya-cho, Hakodate-shi, Hokkaido
TEL
0138-43-8282
Homepage URL
nishimura@hma-ns-reha.ac.jp
Sponsor or person
Institute
Hakodate Medical Association Nursing and Rehabilitation Academy
Institute
Department
Personal name
Funding Source
Organization
Hakodate Medical Association Nursing and Rehabilitation Academy
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
Hakodate Medical Association Nursing and Rehabilitation Academy
Address
5-16 Taya-cho, Hakodate-shi, Hokkaido
Tel
0138-43-8282
nishimura@hma-ns-reha.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 | 02 | Month | 18 | 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 | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | 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
Management information
Registered date
| 2025 | Year | 02 | Month | 17 | Day |
Last modified on
| 2026 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064963
