UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An open trial of respiratory muscle strength training on swallowing and speech dysfunction in patients with Parkinson disease
Title of the study (Brief title)	An open trial of respiratory muscle strength training on swallowing and speech dysfunction in patients with Parkinson disease
Region	Japan

Condition
Condition	Parkinson Disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To test the treatment outcome of respiratory muscle strength training on swallow and speech dysfunction
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Videofluoroscopic Dysphagia Scale, acoustic analyses of voice
Key secondary outcomes	SWAL-QOL scale, maximum expiratory pressure, peak cough flow

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	respiratory muscle strength training
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	meet the diagnostic criteria of the UK Brain Bank step 1 and 2
Key exclusion criteria	difficulty complying due to neuropsychological and motor dysfunctions
Target sample size	6

Research contact person
Name of lead principal investigator	Satoshi Tomita
Organization	Utano National Hospital
Division name	Clinical Research Center
Address	8 Narutaki-Ondoyamachou, Ukyo-ku, Kyoto
TEL	075-461-5121
Email	tomita@unh.hosp.go.jp

Public contact
Name of contact person	Satoshi Tomita
Organization	Utano National Hospital
Division name	Clinical Research Center
Address	8 Narutaki-ondoyamacho Ukyo-ku Kyoto city
TEL	075-461-5121
Homepage URL
Email	tomita@unh.hosp.go.jp

Sponsor
Institute	Clinical Research Center, Utano National Hospital
Institute
Department

Funding Source
Organization	Clinical Research Center, Utano National Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2013 Year 07 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 20 Day
Anticipated trial start date	2013 Year 07 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 07 Month 03 Day
Last modified on	2018 Year 07 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013013