UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034900 |
|---|---|
| Receipt number | R000039791 |
| Scientific Title | Physiotherapy on swallowing function |
| Date of disclosure of the study information | 2018/11/15 |
| Last modified on | 2019/09/15 16:51:28 |
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Basic information
Public title
Physiotherapy on swallowing function
Acronym
Physiotherapy on swallowing function
Scientific Title
Physiotherapy on swallowing function
Scientific Title:Acronym
Physiotherapy on swallowing function
Region
| Japan |
Condition
Condition
Hip fracture and vertebral compression fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to verify whether physiotherapy can contribute to swallowing function improvement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Tongue pressure
Key secondary outcomes
Swallowing function assessed using MASA.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Usual physiotherapy during in-hospital rehabilitation
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients admitted to a rehabilitation hospital for physiotherapy.
2) Sarcopenia diagnosed using AWGS criteria.
Key exclusion criteria
1) Patients prescribed dysphagia rehabilitation
2) Contraindication of measuring body composition
3) Error in measuring body composition
4) Disability in measuring tongue pressure
5) Disability in assessing swallowing function
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | MAEDA |
Organization
Aichi Medical University
Division name
Palliative Care Center
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Japan
TEL
0561-62-3311
kskmaeda@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | MAEDA |
Organization
Aichi Medical University
Division name
Palliative Care Center
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Japan
TEL
0561-62-3311
Homepage URL
kskmaeda@aichi-med-u.ac.jp
Sponsor or person
Institute
Okinawa Chuzan Clinical Research Center, Chuzan Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chuzan Hspital
Address
6-2-1Matsumoto, Okinawa, Japan
Tel
+81-98-982-1346
keiri@chuzan.or.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
ちゅうざん病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 15 | 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
95
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
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 15 | Day |
Last modified on
| 2019 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039791
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
