UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2017 Year 12 Month 12 Day
Date of IRB	2017 Year 12 Month 18 Day
Anticipated trial start date	2017 Year 12 Month 18 Day
Last follow-up date	2018 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	2017 Year 12 Month 15 Day
Last modified on	2020 Year 09 Month 24 Day

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