UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of occupational therapy intervention process for subacute stroke patient: A pilot randomised controlled study
Title of the study (Brief title)	occupational therapy intervention process
Region	Japan

Condition
Condition	subacute stroke patients
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In the present study we will investigate the effects of occupational therapy for subacute stroke patient, in comparison with bottom-up and top-down approach.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	SF-36(MOS 36-Item Short-Form Health Survey)
Key secondary outcomes	Functional independent measure (FIM) Client satisfaction questionnaire(CSQ-8) Brunnstrom recovery stage

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	In the bottom-up (BOT) group, occupational therapists focus evaluations on the patients generic abilities (i.e., boby functions and structures according to the ICF) and personal activities of daily living (P-ADL). During the hospital stay, majority interventions (had to be more than 2/3) was 'Basic function exercise' and 'Simulated occupation practice', and as appropriate, intervention in BOT group was allowed the 'Real-occupationnal practice (P-ADL)' and 'Real-occupational practice (except for P-ADL) within the range of 1/3.
Interventions/Control_2	In the top-down (TOP) group, patient and occupational therapists begins to share and identifiy meaningful occupations for the patient by using Aid for Decision-making in Occupation Choice (ADOC). Then, occupational therapist observes the meaningful occupation and analyzed occupational performance. Interventions focuses on enabling the occupation. During the hospital stay, majority interventions (had to be more than 2/3) was 'Real-occupationnal practice (P-ADL)' and 'Real-occupational practice (except for P-ADL)', and as appropriate, intervention in TOP group was allowed the 'Basic function exercise' and 'Simulated occupation practice' within the range of 1/3.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	This study of participation include patients with hemiparesis in the subacute stage of stroke who were hospitalized at Kaifukuki rehabilitation ward. Stroke was caused by a cerebral infarct or intracerebral hemorrhageonset; onset &#8805;30 days; no major cognitive deficits (24 of 30 on the Mini-Mental State Examination), aphasia or depression as an obstacle to daily living.
Key exclusion criteria	We excluded patient who had cardiac or progressive disease and could not carry on occupational therapy as judged by a primary doctor.
Target sample size	40

Research contact person
Name of lead principal investigator	Kounosuke Tomori
Organization	Kanagawa University of Human Services
Division name	Dividion of Occupational therapy
Address	1-10-1 Heiseicho Yokosuka city
TEL	046-828-2724
Email	adoc.project@gmail.com

Public contact
Name of contact person	Kounosuke Tomori
Organization	Kanagawa University of Human Services
Division name	Dividion of Occupational therapy
Address	1-10-1 Heiseicho Yokosuka city
TEL	046-828-2724
Homepage URL
Email	adoc.project@gmail.com

Sponsor
Institute	Kounosuke Tomori
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 30 Day
Anticipated trial start date	2012 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 01 Month 25 Day
Last modified on	2016 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015147