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
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
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
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
