UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022965
Receipt number 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 2020/07/08 09:56:13

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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 Takefumi
Middle name
Last name Sugiyama

Organization

Kawasaki medical school

Division name

Department of Rehabilitation

Zip code

7010192

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 Takefumi
Middle name
Last name Sugiyama

Organization

Kawasaki medical school

Division name

Department of Rehabilitation

Zip code

7010192

Address

577, Matsushima, Kurashiki-shi, Okayama,

TEL

086-462-1111

Homepage URL


Email

t.sugiyama@med.kawasaki-m.ac.jp


Sponsor or person

Institute

Kibikogen Rehabilitation Center for Employment Injuries

Institute

Department

Personal name



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

Ethics committee of Kibikogen Rehabilitation Center for Employment Injuries

Address

7511 Yoshikawa Kibichuo-cho, Kaga-gun, Okayama-ken

Tel

0866-56-7141

Email

syomu@kibirihah.johas.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

2016 Year 07 Month 01 Day


Related information

URL releasing protocol

http://igakkai.kms-igakkai.com/wp/wp-content/uploads/2020en/KMJ-E202046009.pdf

Publication of results

Published


Result

URL related to results and publications

http://igakkai.kms-igakkai.com/wp/wp-content/uploads/2020en/KMJ-E202046009.pdf

Number of participants that the trial has enrolled

14

Results

Fourteen male patients with chronic cervical spinal cord injuries were included in this study.
VCW was significantly greater during MI-E of > +/-40 cmH2O than during deep breath.
VUT and VLT was significantly greater during MI-E of > +/-30 cmH2O than during deep breath.

Results date posted

2020 Year 07 Month 08 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 02 Month 25 Day

Baseline Characteristics

Patients with chronic cervical spinal cord injuries who did not receive MI-E, had spontaneous respiration.

Participant flow

Subjects visited the outpatient clinic of Kibikogen Rehabilitation Center for Employment Injuries on a regular basis between May 2016 and January 2017 were recruited.

Adverse events

nothing

Outcome measures

VCW, VUT, VLT, VAB.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 03 Month 17 Day

Date of IRB

2016 Year 04 Month 06 Day

Anticipated trial start date

2016 Year 03 Month 17 Day

Last follow-up date

2019 Year 03 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

2016 Year 07 Month 01 Day

Last modified on

2020 Year 07 Month 08 Day



Link to view the page

Value
https://center6.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