UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of intervention based on occupational interview on activities of daily living/instrumental activities of daily living in clients with acute stroke.
Title of the study (Brief title)	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	Shiho Ishida
Organization	Shimane university hospital
Division name	Division of rehabilitation
Address	89-1 Enyacho, Izumo, Shimane, Japan
TEL	0853-20-2457
Email	shiho.112988@gmail.com

Public contact
Name of contact person	Shiho Ishida
Organization	Shimane university hospital
Division name	Division or rehabilitation
Address	89-1 Enyacho, Izumo, Shimane, Japan
TEL	0853-20-2457
Homepage URL
Email	shiho.112988@gmail.com

Sponsor
Institute	Shimane university
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031025