UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029939 |
|---|---|
| Receipt number | R000033436 |
| Scientific Title | Long-term follow-up of dysphagia in adult patients with Duchenne muscular dystrophy. |
| Date of disclosure of the study information | 2017/11/12 |
| Last modified on | 2022/03/29 14:19:04 |
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Basic information
Public title
Long-term follow-up of dysphagia in adult patients with Duchenne muscular dystrophy.
Acronym
Long-term follow-up of dysphagia in adult patients with Duchenne muscular dystrophy.
Scientific Title
Long-term follow-up of dysphagia in adult patients with Duchenne muscular dystrophy.
Scientific Title:Acronym
Long-term follow-up of dysphagia in adult patients with Duchenne muscular dystrophy.
Region
| Japan |
Condition
Condition
Duchenne muscular dystrophy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the prognosis of swallowing function in adult patients with DMD
Basic objectives2
Others
Basic objectives -Others
to identify the important independent clinical factors of the prognosis of swallowing function
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Time Course of the NdSSS for 6 years, from 2010 to 2016.
Key secondary outcomes
the predictive factors of tube feeding (age, Swinyard stage, BMI, BNP, serum albumin, respiratory status, NdSSS)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
consecutive inpatients with DMD to Higashi-Saitama National Hospital for long-term care wards and short-term evaluation on January 2010.
Key exclusion criteria
patients who refused the assessment.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Yamada |
Organization
National Hospital Organization Higashi Saitama Hospital
Division name
Rehabilitation
Zip code
349-0122
Address
4147, Kurohama, Hsuda, Saitama, Japan
TEL
048-768-1161
yyamada-kmm@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Yamada |
Organization
National Hospital Organization Higashi Saitama Hospital
Division name
Rehabilitation
Zip code
349-0122
Address
4147, Kurohama, Hsuda, Saitama, Japan
TEL
048-768-1161
Homepage URL
yyamada-kmm@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Higashi Saitama Hospital
Institute
Department
Personal name
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 Hospital Organization Higashi Saitama Hospital
Address
4147, Kurohama, Hsuda, Saitama, Japan
Tel
048-768-1161
yyamada-kmm@umin.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
| 2017 | Year | 11 | Month | 12 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/abs/pii/S1090379818301867
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S1090379818301867
Number of participants that the trial has enrolled
81
Results
NdSSS was related to age, functional ability assessed using the Swinyard staging and the status of ventilator dependence. Median NdSSS changed from 6 to 4, 4 and 3 over
the 4 time points. Number of patients with tube feeding increased by 5-10% every 2 years.
Initial NdSSS was a predictor of future swallowing status.
Results date posted
| 2022 | Year | 03 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
age(average)26.9+-7.8
Swinyard(median)7
NdSSS(median)5
Participant flow
N/A for retrospective cohort study
Adverse events
N/A for retrospective cohort study
Outcome measures
Swallowing status; Neuromuscular Disease Swallowing Status Scale (NdSSS)
Physical functional ability; Swinyard'sCriteria for Rating Eight Stages of Functional Ability.
Nutrition status;BMI
Respiratory and cardiac functions; PaCO2 and PaO2 and BNP hormone level, Status of ventilator dependence
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observing about the feeding situation every year, change the physical function and the presence of complications.
Management information
Registered date
| 2017 | Year | 11 | Month | 12 | Day |
Last modified on
| 2022 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033436
| 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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