UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030835
Receipt number 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 16:31:56

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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 or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034966