UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053209 |
|---|---|
| Receipt number | R000060725 |
| Scientific Title | Analysis of various factors and determination of rehabilitation effectiveness in patients admitted to a Comprehensive Rehabilitation Ward. |
| Date of disclosure of the study information | 2023/12/24 |
| Last modified on | 2023/12/23 17:19:57 |
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Basic information
Public title
Analysis of various factors and determination of rehabilitation effectiveness in patients admitted to a Comprehensive Rehabilitation Ward.
Acronym
Analysis of rehabilitation effectiveness in patients admitted to a Comprehensive Rehabilitation Ward.
Scientific Title
Analysis of various factors and determination of rehabilitation effectiveness in patients admitted to a Comprehensive Rehabilitation Ward.
Scientific Title:Acronym
Analysis of rehabilitation effectiveness in patients admitted to a Comprehensive Rehabilitation Ward.
Region
| Japan |
Condition
Condition
Cerebrovascular disorders, musculoskeletal disorders, etc.
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are three main objectives of this study.
One is factor analysis, a typical example of which is return prediction analysis. The first objective is to improve the accuracy of outcome prediction by analyzing the progress of physical function and ability to perform activities of daily living of patients admitted to a rehabilitation ward, and to analyze the relationship between each factor and make it useful.
Basic objectives2
Others
Basic objectives -Others
The second objective is to determine the effectiveness of treatment and various initiatives.
The third objective is to investigate and organize incident and near-miss reports in the Rehabilitation Unit, identify problems, and formulate countermeasures. In particular, the analysis of near-miss reports can be valuable because there have been few reports on this topic in previous studies.
We believe that the results of these analyses have a certain significance because they will be applied to future hospitalized patients.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
functional independence measure
Key secondary outcomes
a. Basic information
Age, primary disease, medical history, date of onset, date of admission and discharge, number of hours of practice, brain imaging information, radiographic information, movement ability
video information, state of consciousness, nutritional status, social resource information, orthotics and assistive devices used, problems, standard tasks, etc.
b. Information based on evaluation
b-1. Physical function assessment
Stroke Impairment Assessment Set (SIAS) American Spinal Injury Association (ASIA),
Frankel's classification, muscle strength, joint range of motion assessment, etc.
b-2. Ability assessment
Walking time and distance factors (speed, cadence, stride,
(speed, cadence, stride, number of steps, etc.), Functional Ambulation Categories (FAC), Gait Ability Assessment for hemiplegics
(GAA), Test for Aphasia and Dysarthria (STAD), Independence Checklist, etc.
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 and Female
Key inclusion criteria
Patients with first stroke
Key exclusion criteria
1. Patients with infratentorial lesions,
subarachnoid hemorrhage, multiple lesions
2. Past history of stroke
3. Need assistance in ADL before illness
4. Onset to admission interval after 120 days
5. Hospitalization for 6 days or less
6. Sudden deterioration of symptoms
7. No paralysis
Target sample size
2900
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Sakurai |
Organization
Fujita Health University
Division name
Department of Rehabilitation
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192, JAPAN
TEL
0562-93-2000
hsakurai@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Kawakami |
Organization
Fujita Health University Nanakuri Memorial Hospital
Division name
Division of Rehabilitation
Zip code
514-1295
Address
424-1, Oodoricho, Tsu, Mie, 514-1295, Japan
TEL
059-252-1555
Homepage URL
kenji07n@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
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
Fujita Health University Ceitified Review Board
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192, JAPAN
Tel
0562-93-2865
f-irb@fujita-hu.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
京都リハビリテーション病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
This study will observe the progress of physical function and ability to perform activities of daily living in hospitalized stroke patients
Management information
Registered date
| 2023 | Year | 12 | Month | 23 | Day |
Last modified on
| 2023 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060725
| 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 |
