UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048521 |
|---|---|
| Receipt number | R000055288 |
| Scientific Title | Development of a Comprehensive Rehabilitation System Using ICT: A Prospective Validation Study |
| Date of disclosure of the study information | 2022/07/30 |
| Last modified on | 2024/03/14 19:53:28 |
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Basic information
Public title
Development of a Comprehensive Rehabilitation System Using ICT: A Prospective Validation Study
Acronym
Development of comprehensive rehabilitation system using ICT
Scientific Title
Development of a Comprehensive Rehabilitation System Using ICT: A Prospective Validation Study
Scientific Title:Acronym
Development of comprehensive rehabilitation system using ICT
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishing effective rehabilitation methods using ICT
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eating and swallowing function (FOIS)
Key secondary outcomes
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
Evaluate the items of the rehabilitation system at the beginning of rehabilitation, every week after intervention, and at the end of rehabilitation intervention. The rehabilitation period is the hospitalization rehabilitation intervention period.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A patient aged 20 years or older with dysphagia due to stroke, neuromuscular disease, cancer, or sarcopenia who started inpatient rehabilitation at Nihon University Hospital between August 1, 2022 and March 31, 2024. A score of 5 or less (I take three meals orally, except for the ones that are particularly hard to eat.) on the Functional Oral Intake Scale (FOIS indicates dysphagia. A patient who has taken three meals orally without restriction of food is not considered to have dysphagia.
Key exclusion criteria
A person who has refused to participate in this study
Person judged by the research director to be inappropriate as a research subject
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Nagai |
Organization
Nihon University Hospital
Division name
Rehabilitation medicine
Zip code
173-8610
Address
1-6, Kandasurugadai, chiyoda-ku, Tokyo
TEL
0332931711
ntnyf092@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Nagai |
Organization
Nihon University Hospital
Division name
Rehabilitation medicine
Zip code
173-8610
Address
1-6, Kandasurugadai, chiyoda-ku, Tokyo
TEL
0332931711
Homepage URL
ntnyf092@yahoo.co.jp
Sponsor or person
Institute
Nihon University Hospital
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University hospital
Address
1-6, Kandasurugadai, chiyoda-ku, Tokyo
Tel
0332931711
ntnyf092@yahoo.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
21K11250
Org. issuing International ID_1
KAKENHI
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.jpci.jp/books/view/433
Publication of results
Partially published
Result
URL related to results and publications
https://www.jpci.jp/books/view/433
Number of participants that the trial has enrolled
60
Results
The Functional Oral Intake Scale (FOIS) score, a measure of swallowing function, was significantly improved in the ICT group (p < 0.001). ICT use was considered an influencing factor of FOIS change. ICT use positively affected the Barthel index gain.
Results date posted
| 2024 | Year | 01 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
As a preliminary study, a questionnaire survey was conducted at a regional comprehensive support center in Tokyo on the state of rehabilitation for dysphagia by the long-term care insurance system, and responses were obtained from 56 facilities.
Participant flow
The answer was obtained from 56 facilities (18.9%) out of 296 facilities of regional comprehensive support center in Tokyo 23 wards. 19 (35.2%) of the 56 responding institutions performed swallowing rehabilitation.
Adverse events
None
Outcome measures
Frequency of swallowing rehabilitation and use of ICT
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 30 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055288
| 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 |
