UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021541 |
|---|---|
| Receipt number | R000024833 |
| Scientific Title | Development of the jow opening exercise for improving hyoid excursion during the swallow |
| Date of disclosure of the study information | 2016/03/18 |
| Last modified on | 2016/03/18 19:13:37 |
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Basic information
Public title
Development of the jow opening exercise for improving hyoid excursion during the swallow
Acronym
Development of the jow opening exercise
Scientific Title
Development of the jow opening exercise for improving hyoid excursion during the swallow
Scientific Title:Acronym
Development of the jow opening exercise
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the feasibility and effctiveness of a newly developed modified jaw opening exercise (MJOE) in post-stroke patients with pharyngeal residue who completed a six week exercise regimen.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The two points distance between the chin and hyoid (TPDBCH)
Key secondary outcomes
hyoid displacement (HD)/The presence of pharyngeal residue
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Interventions:modified jaw opening exercise/ upward vertical resistance was applied to the jaw while the mouth was closed with the tongue held in the tipper swallow position to prevent the mouth from opening; one set of five repetitions at 80% maximum voluntary contraction for six week.
Interventions/Control_2
Control: isometric jaw closing exercise/20% maximum voluntary contraction for six week.
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
(1)dysphagia including hypopharyngeal residue found by videofuluorographic swallowing study(VFSS)
(2)the ability to perform the real or sham exercise in this study according to instructions.
Key exclusion criteria
(1)level1 to 4 on the Functional Oral Intake Scale(FOIS)
(2)past or present temporomandibular joint (TMJ) disease and/or tumor of the head and neck.
(3)past or present progressive disease causing dysphagia (e.g., Parkinson's disease).
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Koyama |
Organization
Tokai University Oiso Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
21-2 Gakkyo, Oiso-machi, Naka-gun, Kanagawa 259-0198, Japan
TEL
0463-72-3211
y-koyama@tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Koyama |
Organization
Tokai University Oiso Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
21-2 Gakkyo, Oiso-machi, Naka-gun, Kanagawa 259-0198, Japan
TEL
0463-72-3211
Homepage URL
y-koyama@tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MEXT KAKENHI
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 03 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 18 | Day |
Last modified on
| 2016 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024833
| Research Plan | |
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| 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 |
