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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012955
Receipt No. 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

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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
Institute Kounosuke Tomori
Institute
Department

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
URL(English) https://upload.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


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