UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047997 |
|---|---|
| Receipt number | R000054700 |
| Scientific Title | Primary verification of the impact of listening to songs with lyrics in post-stroke aphasia patients |
| Date of disclosure of the study information | 2022/06/15 |
| Last modified on | 2022/06/08 22:34:29 |
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Basic information
Public title
Impact of music therapy in post-stroke aphasia patients
Acronym
Impact of music therapy in post-stroke aphasia patients
Scientific Title
Primary verification of the impact of listening to songs with lyrics in post-stroke aphasia patients
Scientific Title:Acronym
Primary verification of the impact of listening to songs with lyrics in post-stroke aphasia patients
Region
| Japan |
Condition
Condition
Post-stroke aphasia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An initial investigation into whether listening to music with lyrics improves aphasia in subacute stroke patients, and if so, in what aphasia classifications and in what symptoms of aphasia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in WAB-AQ(Western Aphasia Battery-Aphasia quotient) before and after the 3-month intervention period
Key secondary outcomes
The change in each subset score of the WAB(Western Aphasia Battery) before and after the 3-month intervention period
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Three months of free listening to music with lyrics of the patient's choice for at least one hour per day. Every two weeks, a 15-minute interview with a physician or nurse to check and improve adherence to music listening
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
First stroke patients admitted to the Recovery Rehabilitation Unit of Murayama Medical Center, within 60 days of onset, with aphasia scoring 4 or less on the severity scale of the Boston Diagnostic Aphasia Evaluation, whose attending physician deems them appropriate and who have given written consent
Key exclusion criteria
Native language is not Japanese, severe hearing impairment
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Suzuki |
Organization
Saiseikai Higashikanagawa Rehabilitation Hospital
Division name
Department of Rehabilitation medicine
Zip code
221-0822
Address
1-13-10, Nishi-Kanagawa, Kanagawa-ku, Yokohama, Kanagawa
TEL
045-324-3600
someguya617@gmail.com
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Suzuki |
Organization
Saiseikai Higashikanagawa Rehabilitation Hospital
Division name
Department of Rehabilitation medicine
Zip code
221-0822
Address
1-13-10, Nishi-Kanagawa, Kanagawa-ku, Yokohama, Kanagawa
TEL
045-324-3600
Homepage URL
someguya617@gmail.com
Sponsor or person
Institute
Murayama Medical Center, department of Rehabilitation medicine
Institute
Department
Personal name
Funding Source
Organization
Murayama Medical Center, department of Rehabilitation medicine
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
Murayama Medical Center
Address
2-37-1 Gakuen, Musashimurayama, Tokyo
Tel
042-561-1221
218-murayamahome@mail.hosp.go.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
| 2022 | Year | 06 | Month | 15 | 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
| 2022 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 06 | Month | 08 | Day |
Last modified on
| 2022 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054700
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
