UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052938 |
|---|---|
| Receipt number | R000060400 |
| Scientific Title | A Study of Behavior Disorder Identification Skills by Therapists |
| Date of disclosure of the study information | 2023/11/30 |
| Last modified on | 2023/11/29 03:13:06 |
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Basic information
Public title
A Study of Behavior Disorder Identification Skills by Therapists
Acronym
A Study of Behavior Disorder Identification Skills by Therapists
Scientific Title
A Study of Behavior Disorder Identification Skills by Therapists
Scientific Title:Acronym
A Study of Behavior Disorder Identification Skills by Therapists
Region
| Japan |
Condition
Condition
stroke, hydrocephalus, brain tumor, traumatic encephalopathy, spinocerebellar degeneration, parkinson's disease, pneumonia, heart failure, infection
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify the characteristics of movement observation by rehabilitation therapists
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gaze position
Key secondary outcomes
timing of assistance
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
participant1: stroke, hydrocephalus, brain tumor, traumatic encephalopathy, spinocerebellar degeneration, parkinson's disease, pneumonia, heart failure, infection
participant2: licensed physical therapist, occupational therapist, or speech therapist
Key exclusion criteria
None of the participants had any indications of the following symptoms: (a) orthopedic disorders such as fracture or amputation of the upper limb, (b) severe respiratory or circulatory disease.
And (c) informed consent have not been obtained.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Shotaro |
| Middle name | |
| Last name | Sasaki |
Organization
St Marianna University School of Medicine, Yokohama City Seibu Hospital
Division name
Department of Rehabilitation
Zip code
241-0811
Address
1197-1 Yasashicho, Asahi-ku, Yokohama
TEL
045-366-1111
rehasasaki@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Shotaro |
| Middle name | |
| Last name | Sasaki |
Organization
St Marianna University School of Medicine, Yokohama City Seibu Hospital
Division name
Department of Rehabilitation
Zip code
241-0811
Address
1197-1 Yasashicho, Asahi-ku, Yokohama
TEL
045-366-1111
Homepage URL
rehasasaki@marianna-u.ac.jp
Sponsor or person
Institute
St Marianna University School of Medicine, Yokohama City Seibu 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
St Marianna University School of Medicine, Yokohama City Seibu Hospital
Address
1197-1 Yasashicho, Asahi-ku, Yokohama
Tel
045-366-1111
rehasasaki@marianna-u.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
| 2023 | Year | 11 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
preinitiation
Management information
Registered date
| 2023 | Year | 11 | Month | 29 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060400
| Research Plan | |
|---|---|
| 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 |
