UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059027 |
|---|---|
| Receipt number | R000067511 |
| Scientific Title | Analysis of Factors Associated with ADL Improvement and Rehabilitation Efficacy in Patients Admitted to a Convalescent Rehabilitation Ward: A Retrospective Observational Study |
| Date of disclosure of the study information | 2025/09/08 |
| Last modified on | 2025/09/08 12:16:51 |
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Basic information
Public title
Analysis of Various Factors and Evaluation of Rehabilitation Outcomes in Inpatients of a Rehabilitation Ward
Acronym
Evaluation of Rehabilitation Outcomes for Hospitalized Rehabilitation Patients
Scientific Title
Analysis of Factors Associated with ADL Improvement and Rehabilitation Efficacy in Patients Admitted to a Convalescent Rehabilitation Ward: A Retrospective Observational Study
Scientific Title:Acronym
Analysis of Factors for ADL in Rehabilitation - Convalescent Rehabilitation Ward
Region
| Japan |
Condition
Condition
cerebrovascular disease, musculoskeletal disorders, disuse syndrome, etc.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The first objective of this study is factor analysis, with a primary focus on outcome prediction. By analyzing the progress of physical function and Activities of Daily Living (ADL) in patients admitted to a convalescent rehabilitation ward (CRW), we aim to improve the accuracy of outcome predictions and to clarify the relationships between various factors for clinical application.
The second objective is to evaluate the effectiveness of our treatments and various clinical interventions.
The third objective is to investigate and organize incident and near-miss reports within the CRW to identify problems and develop countermeasures. In particular, the analysis of near-miss reports could be a valuable contribution, as this has been seldom reported in previous studies.
We believe the findings of these analyses will be significant, as they will be applied to the care of future inpatients.
Basic objectives2
Others
Basic objectives -Others
Elucidating the consequences of ADL by disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a. Basic Information
* Age
* Primary disease
* Past medical history
* Date of onset
* Dates of admission and discharge
* Duration of therapy/training
* Brain imaging data
* X-ray imaging data
* Motor ability
* Video data
* Level of consciousness
* Nutritional status
* Information on social resources
* Orthoses and assistive devices used
* Problem list
* Standardized tasks, etc.
b. Information Based on Assessments
b-1. Assessment of Physical Function
* Fugl-Meyer Assessment (FMA)
* American Spinal Injury Association (ASIA) Impairment Scale
* Frankel Classification
* Muscle strength
* Range of Motion (ROM) assessment, etc.
b-2. Assessment of Functional Ability
* Functional Independence Measure (FIM)
* Spatiotemporal gait parameters (e.g., velocity, cadence, stride, step count)
* Functional Ambulation Categories (FAC)
* Gait Ability Assessment for Hemiplegics (GAA) and other gait ability assessments
* Standard Test for Aphasia and Dysarthria (STAD)
* Independence checklist, etc.
Key secondary outcomes
b-3. Assessment of Higher Brain Function
* Hasegawa's Dementia Scale-Revised (HDS-R)
* Mini-Mental State Examination (MMSE)
* Frontal Assessment Battery (FAB)
* Trail Making Test (TMT)
* Kohs Block Design Test (KBDT)
* Cognitive-related Behavioral Assessment (CBA)
* Raven's Colored Progressive Matrices (RCPM), etc.
b-4. Assessment for Aphasia
* Standard Language Test of Aphasia (SLTA)
* Communication effectiveness scales, etc.
b-5. Assessment for Dysarthria
* Assessment of Motor Speech for Dysarthria (AMSD)
* Auditory-perceptual evaluation of hoarseness (GRBAS scale)
* Sound pressure level measurement (e.g., maximum phonation, coughing, conversation)
* Speech intelligibility assessment, etc.
b-6. Assessment for Dysphagia
* Original Inoue-Evaluation for Aspiration Lung Disease (i-EALD)
* Sound pressure level measurement (e.g., maximum phonation, coughing, conversation)
* Oral Health Assessment Tool (OHAT)
* Repetitive Saliva Swallowing Test (RSST)
* Modified Water Swallowing Test (MWST)
* Fujishima's Ingestive and Swallowing ability Scale (FILS)
* Dysphagia Severity Scale (DSS), etc.
c. Information Based on Incident, Accident, and Near-Miss Reports
* Profession/Job title of the staff involved
* Years of experience
* Department/Affiliation
* Incident level/severity
* Date of occurrence
* Fall risk assessment
* Dementia independence level
* Type of incident
* Cause of incident
* Description/Circumstances of the incident
* Response of the patient and family
* Preventive measures and guidance provided, 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
| 40 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients admitted to the recovery rehabilitation ward between April 1, 2020, and March 31, 2030
Key exclusion criteria
Nothing in particular
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Sakurai |
Organization
Fujita Health University
Division name
School of Health Sciences, Faculty of Rehabilitation
Zip code
470-1192
Address
1-98, Dengakugakubo Kutsukake-cho, Toyoake-shi Aichi 470-1192, Japan
TEL
0562-93-2000
kenji07n@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Kawakami |
Organization
Kitaoji Hospital for Neurological Rehabilitation
Division name
Department of Rehabilitation
Zip code
6068171
Address
25-2 Ichijoji Nishimizuhiki-cho, Sakyo-ku, Kyoto-shi.
TEL
0757815111
Homepage URL
kenji07n@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
nothing
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 Research Support Division
Address
1-98, Dengakugakubo Kutsukake-cho, Toyoake-shi 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
脳神経リハビリ北大路病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 08 | 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
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective cohort study.
Management information
Registered date
| 2025 | Year | 09 | Month | 08 | Day |
Last modified on
| 2025 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067511
