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 |
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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 ≥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
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
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
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
