UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030422
Receipt No. R000034721
Scientific Title Study on acquisition protocol of glossopharyngeal breathing in muscular dystrophy patients
Date of disclosure of the study information 2017/12/18
Last modified on 2017/12/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Study on acquisition protocol of glossopharyngeal breathing in muscular dystrophy patients
Acronym Study on acquisition protocol of glossopharyngeal breathing in muscular dystrophy patients
Scientific Title Study on acquisition protocol of glossopharyngeal breathing in muscular dystrophy patients
Scientific Title:Acronym Study on acquisition protocol of glossopharyngeal breathing in muscular dystrophy patients
Region
Japan

Condition
Condition muscular dystrophy
Classification by specialty
Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify whether or not to acquire efficient glossopharyngeal breathing by training based on protocols to acquire glossopharyngeal breathing in muscular dystrophy patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes vital capacity using glossopharyngeal breathing pre- and post intervention
Key secondary outcomes vital capacity, Frenchay Dysarthria Assessment 2 edition, Repetitive saliva swallowing test, specific original evaluation of glossopharyngeal function

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
Maneuver
Interventions/Control_1 Protocol aimed at learning laryngopharyngeal respiration: 10 minutes per session, up to 6 sessions (within 1 month)
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
16 years-old <=
Age-upper limit
40 years-old >=
Gender Male
Key inclusion criteria Diagnosis of muscular dystrophy (excluding myotonic muscular dystrophy)
Hospitalization for our hospital
Implementation of respiratory rehabilitation
Learn the maximum insufflation capacity
Key exclusion criteria Glossopharyngeal breathing already acquired
Cognitive dysfunction and/or intellectual disability
Pain in the glossopharyngeal area
Continuous use of ventilator during daytime
Tracheostomy
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koshiro Haruyama
Organization National Hospital Organization East-Saitama National Hospital
Division name Department of Rehabilitation Medicine, Physical Therapy
Zip code
Address 4147 Kurohama, Hasuda, Saitama 349-0196, Japan
TEL 048-768-1161
Email pt@nhs.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koshiro Haruyama
Organization National Hospital Organization East-Saitama National Hospital
Division name Department of Rehabilitation Medicine, Physical Therapy
Zip code
Address 4147 Kurohama, Hasuda, Saitama 349-0196, Japan
TEL 048-768-1161
Homepage URL
Email pt@nhs.hosp.go.jp

Sponsor
Institute National Hospital Organization East-Saitama National Hospital
Institute
Department

Funding Source
Organization National Hospital Organization East-Saitama National Hospital
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 国立病院機構東埼玉病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 18 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
2017 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 18 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
2017 Year 12 Month 15 Day
Last modified on
2017 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034721

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.