UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052335 |
|---|---|
| Receipt number | R000059753 |
| Scientific Title | Retrospective study of neck flexion muscle strength in patients with swallowing dysfunction |
| Date of disclosure of the study information | 2023/11/20 |
| Last modified on | 2024/04/19 09:10:32 |
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Basic information
Public title
Retrospective study of neck flexion muscle strength in patients with swallowing dysfunction
-Comparison of data before and after the training period-
Acronym
Retrospective study of neck flexion muscle strength in patients with swallowing dysfunction
Scientific Title
Retrospective study of neck flexion muscle strength in patients with swallowing dysfunction
Scientific Title:Acronym
Retrospective study of neck flexion muscle strength in patients with swallowing dysfunction
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively examine changes in neck flexion muscle strength before and after swallowing training.
Basic objectives2
Others
Basic objectives -Others
Comparison of neck flexion strength values and other swallowing-related indicators.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
neck flexion muscle strength
Key secondary outcomes
*Tongue pressure
*lip pressure
*CPF
*FOIS
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with swallowing dysfunction
2) Patients who received ST prescription between April 2023 and December 2023
3) Men and women aged 20 years or older at the time of obtaining consent
4) Persons who have given written consent for research participation
Key exclusion criteria
1)Cases diagnosed with swallowing dysfunction but no ST prescription
2)Cases where subject background information items include missing values
3)Cases where there was an intention to refuse participation by opting out
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sawako |
| Middle name | |
| Last name | Sekiguchi |
Organization
National Center for Global Health and Medicine
Division name
Department of Rehabulitation Medicine
Zip code
1628655
Address
1-21-1,Toyama, Shinjuku-ku, Tokyo
TEL
03-3202-7181
sasekiguchi@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Kikuchi |
Organization
National Center for Global Health and Medicine
Division name
Department of Rehabulitation Medicine
Zip code
1628655
Address
1-21-1,Toyama, Shinjuku-ku, Tokyo
TEL
0332027181
Homepage URL
sasekiguchi@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Kazuko Kikuchi
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine
Address
1-21-1,Toyama, Shinjuku-ku, Tokyo
Tel
03-3202-7181
kenkyu-shinsa@hosp.ncgm.go.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
国立国際医療研究センター
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
37
Results
<Neck muscle strength value>
Initial evaluation:6.4 Final evaluation: 6.9kgf p=0.068
<Comparison of each measurement item value>
･Neck muscle strength
7.3 kgf (Final)7.6 kgf p=0.477
･Tongue pressure
24.1kPa (Final)24.3 kPa p=0.880
･Lip pressure
8.6 (Final)8.7 p=0.816
･CPF
117.9L/min (Final)157.9L/min p=0.035
Tongue pressure:r=0.521, p<.001
Lip pressure:r=0.193, p=0.247
CPF:r=0.541, p<.001
Results date posted
| 2023 | Year | 09 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
<Patient background>
Age:75.4years old
Hospitalization period:42.9days
ST intervention period:35.1days
Height:160.4cm
Weight:48.4kg
BMI:19.2
Participant flow
This study is a retrospective study and uses information from the medical records of the conducting institution. No subject recruitment will be conducted.
Adverse events
None
Outcome measures
*Meal intake status: food form, FOIS
*Neck flexion strength value
*Swallowing-related indicators: tongue pressure, lip pressure, CPF
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 19 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 19 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 19 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 19 | Day |
Other
Other related information
Presented at an academic conference.
Management information
Registered date
| 2023 | Year | 09 | Month | 28 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059753
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