UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057337 |
|---|---|
| Receipt number | R000065525 |
| Scientific Title | A study on the feasibility and benefits of online speech-language therapy for patients with primary progressive aphasia. |
| Date of disclosure of the study information | 2025/03/19 |
| Last modified on | 2025/09/19 11:46:52 |
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Basic information
Public title
A study on the feasibility and benefits of online speech-language therapy for patients with primary progressive aphasia.
Acronym
PPA-OST Study
Scientific Title
A study on the feasibility and benefits of online speech-language therapy for patients with primary progressive aphasia.
Scientific Title:Acronym
PPA-OST Study
Region
| Japan |
Condition
Condition
Primary progressive aphasia
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and effectiveness of remote Speech-Language Therapy using a video conference system for patients with primary progressive aphasia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility of introducing online ST
Annual changes in performance on language training tasks.
Key secondary outcomes
Annual changes in cognitive function (Mini-Mental State Examination, Raven's Coloured Progressive Matrices) and language function (WAB Aphasia Battery).
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention period: Up to three years
Intervention frequency: Forty minutes per session, once per month
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
Aged 20 years or older at the time of obtaining consent.
Individuals who wish to receive remote ST.
Meets the diagnostic criteria for PPA (Gorno-Tempini et al., Neurology, 2011).
Key exclusion criteria
Individuals with a history of organic brain diseases (including a clear history of cerebral infarction, Parkinson's disease, or related disorders) or those diagnosed with a mental disorder.
Individuals with substance-related disorders (e.g., drug dependence).
Individuals with a severe illness or a history of such an illness, whom the sub-investigator deems unsuitable for participation in this study.
Individuals suspected of having severe hearing loss or visual impairment.
Individuals whom the sub-investigator deems unsuitable for participation in this study for other reasons.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Ikeda |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Psychiatry, Course of Integrated Medicine, Division of Internal Medicine.
Zip code
565-0871
Address
D3, 2-2, Yamadaoka, Suita, Osaka, 565-0871,Japan
TEL
06-6879-3051
mikeda@psy.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Takasaki |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Psychiatry, Course of Integrated Medicine, Division of Internal Medicine.
Zip code
565-0871
Address
D3, 2-2, Yamadaoka, Suita, Osaka, 565-0871,Japan
TEL
06-6879-3051
Homepage URL
atakasaki@psy.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university
Institute
Department
Personal name
Funding Source
Organization
Other
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
Osaka University Hospital Ethics Review Committee
Address
4F, Advanced Medical Innovation Center Building, 2-2 Yamadaoka, Suita City, Osaka, Japan.
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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 | 03 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2030 | Year | 01 | 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 | 03 | Month | 19 | Day |
Last modified on
| 2025 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065525
