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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035308
Receipt No. R000040091
Scientific Title Estimation of respiration and cough movement of Parkinson's disease patients by Optoelectronic plethysmography
Date of disclosure of the study information 2018/12/19
Last modified on 2019/05/11

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Basic information
Public title Estimation of respiration and cough movement of Parkinson's disease patients by Optoelectronic plethysmography
Acronym Estimation of respiratory function of Parkinson's disease patients by OEP
Scientific Title Estimation of respiration and cough movement of Parkinson's disease patients by Optoelectronic plethysmography
Scientific Title:Acronym Estimation of respiratory function of Parkinson's disease patients by OEP
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By analyzing the motion of the chest and abdomen accompanying respiration using a three-dimensional motion analysis device, we will clarify the difference in respiratory function between healthy volunteers and PD patients.
Basic objectives2 Others
Basic objectives -Others By estimating the motion of the chest and abdomen by three dimensional motion analysis, we characterize the disorders of breathing exercise, especially coughing. It is expected that this will lead to knowledge leading to effective rehabilitation for the prevention of aspiration pneumonia and improvement of respiratory function.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes changes in thoracoabdominal volume
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Healthy volunteers
Interventions/Control_2 Patient with Parkinson's disease
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
Key inclusion criteria healthy volunteers
Patients with Parkinson's disease
Key exclusion criteria Patients with CVA
Patients with SCI
Patients with degeneration and progressive disease excluded with Parkinson's disease
Patients with fracture in U/E or shoulder
Patients with COPD or chronic pneumoniae
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Masashi
Middle name
Last name YASUNAGA
Organization Kawasaki Medical School Hospital
Division name Rehabilitaion Medicine
Zip code 701-0192
Address 577, Matsushima, Kurashi-city, Okayama, Japan
TEL +81864621111
Email yasnaga1981@gmail.com

Public contact
Name of contact person
1st name Masashi
Middle name
Last name YASUNAGA
Organization Kawasaki Medical School Hospital
Division name Rehabilitaion Medicine
Zip code 701-0192
Address 577, Matsushima, Kurashi-city, Okayama, Japan
TEL +81864621111
Homepage URL
Email yasnaga1981@gmail.com

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
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 Kawasaki Medical School and hospital IRB
Address 577, Matsushima, Kurashi-city, Okayama, Japan
Tel 086-462-1111
Email kmsrec@med.kawasaki-m.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 川崎医科大学附属病院(岡山県)

Other administrative information
Date of disclosure of the study information
2018 Year 12 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 Enrolling by invitation
Date of protocol fixation
2018 Year 12 Month 01 Day
Date of IRB
2019 Year 02 Month 18 Day
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2023 Year 08 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
2018 Year 12 Month 19 Day
Last modified on
2019 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040091

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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