UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035558
Receipt No. 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 2019/04/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email krugreims@yahoo.co.jp

Sponsor
Institute Shonan Keiiku Hospital
Institute
Department

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
Email 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 No longer recruiting
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
2019 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040507

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.