UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035308 |
|---|---|
| Receipt number | 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 | 2023/05/07 14:59:32 |
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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
yasnaga@med.kawasaki-m.ac.jp
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
yasnaga@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://igakkai.kms-igakkai.com/wp/wp-content/uploads/2022en/KMJ-E202248119.pdf
Number of participants that the trial has enrolled
14
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 10 | Month | 03 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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 | 03 | Month | 09 | 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
| 2023 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040091
| 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 |
