UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045378 |
|---|---|
| Receipt number | R000051816 |
| Scientific Title | Therapeutic intervention to improve peak cough flow in patients with multiple system atrophy |
| Date of disclosure of the study information | 2021/09/06 |
| Last modified on | 2024/03/18 09:04:10 |
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Basic information
Public title
Therapeutic intervention to improve peak cough flow in patients with multiple system atrophy
Acronym
Therapeutic intervention to improve peak cough flow in patients with multiple system atrophy
Scientific Title
Therapeutic intervention to improve peak cough flow in patients with multiple system atrophy
Scientific Title:Acronym
Therapeutic intervention to improve peak cough flow in patients with multiple system atrophy
Region
| Japan |
Condition
Condition
Multiple system atrophy
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how much the strength of coughing can be improved by intervention of respiratory physiotherapy in patients with multiple system atrophy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Peak cough flow
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Inspiratory assistance is provided to the study subjects up to the maximum insufflation capacity, and then coughing is performed.
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
| 30 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with probable MSA according to the second consensus statement on the diagnosis of multiple system atrophy(Gilman criteria).
Key exclusion criteria
1;Respiratory disease
2;Heart disease
3;Neoplastic disease
4; Patients with other neurological or neuromuscular disorders
5;Acute or chronic inflammatory and infectious diseases
6;Patients who have undergone tracheostomy or who are using tracheostomy ventilation therapy
7;Patients who cannot communicate at all due to severe dementia
8;Patients who cannot communicate at all due to communication disorders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Asakawa |
Organization
International university of health and welfare Graduate School of Medicine, Department of Clinical Medical Sciences, Rehabilitation Medicine
Division name
Department of rehabilitation
Zip code
272-0827
Address
6-1-14, Konodai, Ichikawa city, Chiba prefecture, Japan
TEL
047-375-1111
takashi.rpt@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Asakawa |
Organization
International university of health and welfare ICHIKAWA hospital
Division name
Rehabilitation
Zip code
272-0827
Address
6-1-14, Konodai, Ichikawa city, Chiba prefecture, Japan
TEL
047-375-1111
Homepage URL
takashi.rpt@gmail.com
Sponsor or person
Institute
International university of health and welfare ICHIKAWA hospital, Dep, of rehabilitation
Institute
Department
Personal name
Funding Source
Organization
International university of health and welfare ICHIKAWA hospital, Dep, of rehabilitation
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
International University of Health and Welfare Chiba District Ethics Review Board
Address
4-3, Kozunomori, Narita city, Chiba prefecture, Japan
Tel
0476-20-7708
rinri_md@iuhw.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
| 2021 | Year | 09 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC105
Number of participants that the trial has enrolled
18
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
Main results already published
Date of protocol fixation
| 2021 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 04 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051816
| 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 |
