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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030420
Receipt No. 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 2019/04/01

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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
Email 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
Email tahara.masayuki.ne@mail.hosp.go.jp

Sponsor
Institute Clinical Research Center, NHO Utano National Hospital
Institute
Department

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
Email 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 Open public recruiting
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
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034733

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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