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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022965
Receipt No. R000026472
Scientific Title Chest wall kinematicsin and efficacy of Insufflation-Exsufflation in cervical spinal cord injury
Date of disclosure of the study information 2016/07/01
Last modified on 2018/08/09

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Basic information
Public title Chest wall kinematicsin and efficacy of Insufflation-Exsufflation in cervical spinal cord injury
Acronym Chest wall kinematicsin and efficacy of Insufflation-Exsufflation in cervical spinal cord injury
Scientific Title Chest wall kinematicsin and efficacy of Insufflation-Exsufflation in cervical spinal cord injury
Scientific Title:Acronym Chest wall kinematicsin and efficacy of Insufflation-Exsufflation in cervical spinal cord injury
Region
Japan

Condition
Condition cervical spinal cord injury
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 efficacy of Insufflation-Exsufflation in cervical spinal cord injury
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes CPF, VC, FEV1.0, PEmax, PImax
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Useing in the following pressure the MIE in the cervical spinal cord injury patients.
+30/-30 cmH2O, +40/-40 cmH2O, +50/-50 cmH2O.
one day, 3 times.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1. Without acute respiratory disease history of the research before 4 weeks.

2. Without history of respiratory disease due to factors other than those associated with cervical spinal cord injury
Key exclusion criteria 1. severe cardiac function
2. history of the disease, such as to affect the breathing.
In particular, a history of airway damage, pneumothorax,mediastinal emphysema.
3. symptoms of acute disease of the upper and lower respiratory tract.
4. face mask can not be attached
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takefumi Sugiyama
Organization Kawasaki medical school
Division name Department of Rehabilitation
Zip code
Address 577, Matsushima, Kurashiki-shi, Okayama,
TEL 086-462-1111
Email t.sugiyama@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takefumi Sugiyama
Organization Kawasaki medical school
Division name Department of Rehabilitation
Zip code
Address 577, Matsushima, Kurashiki-shi, Okayama,
TEL 086-462-1111
Homepage URL
Email t.sugiyama@med.kawasaki-m.ac.jp

Sponsor
Institute Kibikogen Rehabilitation Center for Employment Injuries
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://igakkai.kms-igakkai.com/wp/wp-content/uploads/2017en/KMJ-E43(2)95.pdf
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 No longer recruiting
Date of protocol fixation
2016 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 01 Day
Last modified on
2018 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026472

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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