UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011109 |
|---|---|
| Receipt number | R000013013 |
| Scientific Title | An open trial of respiratory muscle strength training on swallowing and speech dysfunction in patients with Parkinson disease |
| Date of disclosure of the study information | 2013/07/05 |
| Last modified on | 2018/07/07 18:43:31 |
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Basic information
Public title
An open trial of respiratory muscle strength training on swallowing and speech dysfunction in patients with Parkinson disease
Acronym
An open trial of respiratory muscle strength training on swallowing and speech dysfunction in patients with Parkinson disease
Scientific Title
An open trial of respiratory muscle strength training on swallowing and speech dysfunction in patients with Parkinson disease
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Satoshi Tomita |
Organization
Utano National Hospital
Division name
Clinical Research Center
Zip code
Address
8 Narutaki-Ondoyamachou, Ukyo-ku, Kyoto
TEL
075-461-5121
tomita@unh.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Tomita |
Organization
Utano National Hospital
Division name
Clinical Research Center
Zip code
Address
8 Narutaki-ondoyamacho Ukyo-ku Kyoto city
TEL
075-461-5121
Homepage URL
tomita@unh.hosp.go.jp
Sponsor or person
Institute
Clinical Research Center, Utano National Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2013 | Year | 06 | Month | 20 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013013
