UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019747 |
|---|---|
| Receipt number | R000022708 |
| Scientific Title | The effect of ice massage using a new device for patient with dysphagia. |
| Date of disclosure of the study information | 2015/11/16 |
| Last modified on | 2023/05/25 16:55:46 |
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Basic information
Public title
The effect of ice massage using a new device for patient with dysphagia.
Acronym
New ice massage device for dysphagia.
Scientific Title
The effect of ice massage using a new device for patient with dysphagia.
Scientific Title:Acronym
New ice massage device for dysphagia.
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the effect of new ice massage device for eliciting the swallow reflex.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The latency between the command of dry swallowing and the triggering of the swallow reflex.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients are trained with new ice massage device once per case.
Interventions/Control_2
Patients are trained with past ice massage device once per case.
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 dysphagia
Key exclusion criteria
Those who could not command
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Tazawa |
Organization
Gunma university graduate school of medeicine
Division name
Department of rehabilitation medicine
Zip code
3718511
Address
3-39-15 Showa-machi , Maebashi , Gunma, Japan
TEL
0272578655
mastaz1@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Tazawa |
Organization
Gunma University Graduate School of Medicine
Division name
Department of rehabilitation medicine
Zip code
3718511
Address
3-39-15 Showa-machi , Maebashi , Gunma, Japan
TEL
0272578655
Homepage URL
mastaz1@gunma-u.ac.jp
Sponsor or person
Institute
Gunma university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi paper mills limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Univesity Hospital Clinical Research Center
Address
3-39-15 Showa-machi , Maebashi , Gunma, Japan
Tel
027-220-8740
esaitoh@gunma-u.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
| 2015 | Year | 11 | Month | 16 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_reg_list.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_reg_list.cgi
Number of participants that the trial has enrolled
48
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
be analyzing date now
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 11 | Day |
Last modified on
| 2023 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022708
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
