UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030420 |
|---|---|
| Receipt number | R000034733 |
| Scientific Title | Specific task for assessing dysarthria in Japanese patients with Parkinson's disease using speech analysis |
| Date of disclosure of the study information | 2017/12/15 |
| Last modified on | 2023/07/21 12:21:15 |
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Basic information
Public title
Specific task for assessing dysarthria in Japanese patients with Parkinson's disease using speech analysis
Acronym
STart-JPDs
Scientific Title
Specific task for assessing dysarthria in Japanese patients with Parkinson's disease using speech analysis
Scientific Title:Acronym
STart-JPDs
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the speech features of dysarthria in Japanese patients with Parkinson's disease using speech analysis
Basic objectives2
Others
Basic objectives -Others
To clarify specific tasks suitable for detecting dysarthria
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To analyze acoustic parameters of speech voices recorded during speak tasks using speech analysis
Key secondary outcomes
To investigate the association between clinical profiles and acoustic parameters
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 55 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) In-patients or out-patients who had been diagnosed with idiopathic Parkinson's disease based on the United Kingdom's Parkinson's disease diagnostic criteria (steps 1 and 2);
2) Aged between 55 and 85 years;
3) Any gender;
4) Provided written informed consent;
5) Good cooperation and able to follow the study protocol.
Key exclusion criteria
1) Patients without any organic lesions of the laryngopharynx;
2) Patients who show dysarthria due to other apparent reasons (long-term smoking, drinking habits, etc.);
3) Patients unable to read aloud and recite words due to severe dementia;
4) Patients unable to read aloud due to visual impairment;
5) Patients who have undergone deep brain stimulation surgery and have an artificial cochlea;
6) Patients whose native language is not Japanese;
7) Patients considered unfit for the investigation.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | Kanehara |
Organization
NHO Utano National Hospital
Division name
Department of Rehabilitation
Zip code
6168255
Address
8 Ondoyma-cho, Narutaki, Ukyo-ku, Kyoto
TEL
075-461-5121
kanehara.haruka.ap@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Tahara |
Organization
NHO Utano National Hospital
Division name
Department of Rehabilitation
Zip code
6168255
Address
8 Ondoyma-cho, Narutaki, Ukyo-ku, Kyoto
TEL
075-461-5121
Homepage URL
tahara.masayuki.ne@mail.hosp.go.jp
Sponsor or person
Institute
Clinical Research Center, NHO Utano National Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Speech and Hearing Sciences and Disorders, Faculty of Health and Medicai Scienses, Kyoto Gakuen University
Makoto Kariyasu
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, NHO Utano National Hospital
Address
8 Ondoyma-cho, Narutaki, Ukyo-ku, Kyoto
Tel
075-461-5121
mori.yosuke.kc@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
| 2017 | Year | 12 | 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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Speech analysis by computer speech lab CSL4500 (Kay PENTAX)
Management information
Registered date
| 2017 | Year | 12 | Month | 15 | Day |
Last modified on
| 2023 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034733
| 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 |
