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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030835
Receipt No. R000034966
Scientific Title Effect of voice therapy for aged atrophy
Date of disclosure of the study information 2018/06/01
Last modified on 2021/07/20

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Basic information
Public title Effect of voice therapy for aged atrophy
Acronym Effect of voice therapy for aged atrophy
Scientific Title Effect of voice therapy for aged atrophy
Scientific Title:Acronym Effect of voice therapy for aged atrophy
Region
Japan

Condition
Condition aged atrophy
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study examine the effect of voice therapy for aged atrophy using electromyography and voice assessments.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The activity of Thyroarytenoid muscle between pre and post voice therapy
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
60 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria - The patients who agreed with the participant of this study
- The patients who were diagnosed as aged atrophy
- The patients who were not diagnosed as vocal fold polyp, nodule, edema, tumor, paresis or paralysis
- Performance Status Grade,0-1
Key exclusion criteria - The patients who were treated with dadiation for larynx
- The patients who were treated for larynx tumor
- The patients who were treated for trachea burn
- The patients who are treated for sever heart or lung disease
- The patients who are judged inappropriate by doctor
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Shigeru
Middle name
Last name Hirano
Organization Kyoto Prefectural University of Medicine
Division name Department of Otolaryngology Head & Neck Suegery
Zip code 6028566
Address 465, Kajii-cho, Kamigyo-ku, Kyoto-city
TEL 075-251-5603
Email hirano@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Mami
Middle name
Last name Kaneko
Organization Kyoto Prefectural University of Medicine
Division name Department of Otolaryngology Head & Neck Suegery
Zip code 6028566
Address 465, Kajii-cho, Kamigyo-ku, Kyoto-city
TEL 075-251-5603
Homepage URL
Email mkaneko@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization self
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization KPUM IRB
Address Kajii-cyo, Kamigyo-ku, Kyoto
Tel 0752515337
Email rinri@koto.kpu-m.ac.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
2018 Year 06 Month 01 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 10
Results Vocal assessments and thyroarytenoid muscle activity significantly improved at post voice therapy.
Results date posted
2021 Year 01 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events None.
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 06 Month 01 Day
Date of IRB
2018 Year 06 Month 01 Day
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
2021 Year 07 Month 20 Day
Date trial data considered complete
2021 Year 07 Month 20 Day
Date analysis concluded
2021 Year 07 Month 20 Day

Other
Other related information Nothing

Management information
Registered date
2018 Year 01 Month 16 Day
Last modified on
2021 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034966

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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