UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037703 |
|---|---|
| Receipt number | R000042998 |
| Scientific Title | Efficacy of EMG biofeedback therapy for muscle tension dysphonia and spasmodic dysphonia. |
| Date of disclosure of the study information | 2019/08/16 |
| Last modified on | 2024/02/20 12:27:45 |
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Basic information
Public title
Efficacy of EMG biofeedback therapy for muscle tension dysphonia and spasmodic dysphonia.
Acronym
Efficacy of EMG biofeedback therapy for voice disorders.
Scientific Title
Efficacy of EMG biofeedback therapy for muscle tension dysphonia and spasmodic dysphonia.
Scientific Title:Acronym
Efficacy of EMG biofeedback therapy for voice disorders.
Region
| Japan |
Condition
Condition
Muscle tension dysphonia, spasmodic dysphonia
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The laryngeal surface EMG is used to measure the excess muscle activity in patients with voice disorders on the same time axis as the acoustic. To investigate the therapeutic effect of biofeedback therapy using surface EMG.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Difference in total VHI score before and after treatment.
Key secondary outcomes
Laryngeal muscle activity before and at the end of treatment.
Voice function before treatment and at the end of treatment (Mean flow rate, GRBAS score, Jitter, Shimmer).
Laryngeal endoscopy findings before and at the end of treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Voice therapy is performed in 2 groups for 1 to 3 months using techniques to relieve muscle tone.
Interventions/Control_2
In the group with biofeedback, the laryngeal surface EMG is used to monitor muscular activity during phonation, and voice therapy is performed while feedback is provided by the examiner / patient. In the group without biofeedback, voice therapy is performed using techniques to relieve muscle tone.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with muscle tension dysphonia or spasmodic dysphonia who have been judged to have voice therapy.
Key exclusion criteria
A person with a history of cerebrovascular disorder or neurodegenerative disease.
Person who has received voice therapy.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Mizoguchi |
Organization
Hokkaido University Hospital
Division name
Oto-rhino-laryngology
Zip code
060-8648
Address
Kita14, Nishi5, Kita-Ku, Sapporo, Hokkaido, Japan.
TEL
011-716-1161
jibika-sec@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Yanagida |
Organization
Health Sciences University of Hokkaido
Division name
School of Rehabilitation Sciences
Zip code
061-0293
Address
1757 Kanazawa, Tobetsu-cho, Ishikari-gun, Hokkaido, Japan.
TEL
0133-23-1051
Homepage URL
s.yanagi@hoku-iryo-u.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Health Sciences University of Hokkaido Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Division of Clinical Research Administration
Address
Kita14, Nishi5, Kita-Ku, Sapporo, Hokkaido, Japan.
Tel
011-701-7636
crjimu@huhp.hokudai.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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 16 | Day |
Last modified on
| 2024 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042998
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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