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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034900
Receipt No. R000039791
Scientific Title Physiotherapy on swallowing function
Date of disclosure of the study information 2018/11/15
Last modified on 2019/08/15

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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 150

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
Email 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
Email kskmaeda@aichi-med-u.ac.jp

Sponsor
Institute Okinawa Chuzan Clinical Research Center, Chuzan Hospital
Institute
Department

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
Email 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
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 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039791

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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