UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012955
Receipt number R000015147
Scientific Title Comparison of occupational therapy intervention process for subacute stroke patient: A pilot randomised controlled study
Date of disclosure of the study information 2014/01/25
Last modified on 2016/05/16 08:50:51

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Comparison of occupational therapy intervention process for subacute stroke patient: A pilot randomised controlled study

Acronym

occupational therapy intervention process

Scientific Title

Comparison of occupational therapy intervention process for subacute stroke patient: A pilot randomised controlled study

Scientific Title:Acronym

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


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



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

1st name
Middle name
Last name Kounosuke Tomori

Organization

Kanagawa University of Human Services

Division name

Dividion of Occupational therapy

Zip code


Address

1-10-1 Heiseicho Yokosuka city

TEL

046-828-2724

Email

adoc.project@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Kounosuke Tomori

Organization

Kanagawa University of Human Services

Division name

Dividion of Occupational therapy

Zip code


Address

1-10-1 Heiseicho Yokosuka city

TEL

046-828-2724

Homepage URL


Email

adoc.project@gmail.com


Sponsor or person

Institute

Kounosuke Tomori

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

2012 Year 06 Month 30 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015147


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name