UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035558 |
|---|---|
| Receipt number | R000040507 |
| Scientific Title | Relationships between musical functions, clinical symptoms and brain function in patients with stroke |
| Date of disclosure of the study information | 2019/01/16 |
| Last modified on | 2020/04/20 11:51:30 |
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Basic information
Public title
Relationships between musical functions, clinical symptoms and brain function in patients with stroke
Acronym
Relationships between musical functions, clinical symptoms and brain function in patients with stroke
Scientific Title
Relationships between musical functions, clinical symptoms and brain function in patients with stroke
Scientific Title:Acronym
Relationships between musical functions, clinical symptoms and brain function in patients with stroke
Region
| Japan |
Condition
Condition
stroke, healthy control
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate relationships between musical functions, clinical symptoms and brain activity in patients with stroke
Basic objectives2
Others
Basic objectives -Others
cross-sectional study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluations of musical functions
Key secondary outcomes
motor functions, cognitive deficits, MRI, NIRS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Evaluations of musical functions
Evaluations of motor and cognitive impairments
MRI
NIRS
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)first ever stroke, or recurrent stroke within the same hemisphere
2) more than one month from the onset
3) seating endurance of one hour
Key exclusion criteria
1) serious medical conditions
2) severe cognitive deficits not to understand research plan
3) motor impairment on the unaffected upper limb
4) visual and hearing impairments that preclude evaluations of musical functions
5) skull defects
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Keiichiro |
| Middle name | |
| Last name | Shindo |
Organization
Shonan Keiiku Hospital
Division name
Department of rehabilitation medicine
Zip code
252-0816
Address
4360 Endo, Fujisawa city, Kanagawa Prefecture
TEL
0466-48-0050
krugreims@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Keiichiro |
| Middle name | |
| Last name | Shindo |
Organization
Shonan Keiiku Hospital
Division name
Department of rehabilitation medicine
Zip code
252-0816
Address
4360 Endo, Fujisawa city, Kanagawa Prefecture
TEL
0466-48-0050
Homepage URL
krugreims@yahoo.co.jp
Sponsor or person
Institute
Shonan Keiiku Hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
Ethics committee of Shonan Keiiku Hospital
Address
4360 Endo, Fujisawa-city, Kanagawa
Tel
0466-48-0050
K-miyazaki@keiiku.gr.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
| 2019 | Year | 01 | 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
34
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
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 16 | Day |
Last modified on
| 2020 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040507
