UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027066 |
|---|---|
| Receipt number | R000031025 |
| Scientific Title | Effect of intervention based on occupational interview on activities of daily living/instrumental activities of daily living in clients with acute stroke. |
| Date of disclosure of the study information | 2017/04/19 |
| Last modified on | 2018/06/21 17:08:42 |
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Basic information
Public title
Effect of intervention based on occupational interview on activities of daily living/instrumental activities of daily living in clients with acute stroke.
Acronym
Effect of intervention based on occupational interview on activities of daily living/instrumental activities of daily living in clients with acute stroke.
Scientific Title
Effect of intervention based on occupational interview on activities of daily living/instrumental activities of daily living in clients with acute stroke.
Scientific Title:Acronym
Effect of intervention based on occupational interview on activities of daily living/instrumental activities of daily living in clients with acute stroke.
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate the effect of intervention based on occupational therapy interviewing on patients with acute phase of stroke on the performance of daily living activities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The assessment of Motor and Process Skills (AMPS)
(First occupational therapy session and last session)
Key secondary outcomes
Stroke Impairment Assessment
Functional independence Measure
Questionnaire of perception about health care
Questionnaire of living condition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention based on interview by Canadian occupational performance measure (our hospital stay)
Interventions/Control_2
No interview by Canadian occupational performance measure (our hospital stay)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Stroke patients who received the diagnosis in our hospital
2)Patients who are judged necessary for occupational therapy by a rehabilitation specialist
3)Mini-Mental State Examination(MMSE)>24
4)Patients who consent is obtained
Key exclusion criteria
1)No dementia
2)No disturbance of consciousness
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiho Ishida |
Organization
Shimane university hospital
Division name
Division of rehabilitation
Zip code
Address
89-1 Enyacho, Izumo, Shimane, Japan
TEL
0853-20-2457
shiho.112988@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiho Ishida |
Organization
Shimane university hospital
Division name
Division or rehabilitation
Zip code
Address
89-1 Enyacho, Izumo, Shimane, Japan
TEL
0853-20-2457
Homepage URL
shiho.112988@gmail.com
Sponsor or person
Institute
Shimane university
Institute
Department
Personal name
Funding Source
Organization
NO
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
Address
Tel
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
島根大学医学部附属病院（島根県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 19 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 19 | Day |
Last modified on
| 2018 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031025
