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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043608
Receipt No. R000049792
Scientific Title Extraction of factors affecting the effect of Occupational Therapy Intervention Process Model on stroke patients
Date of disclosure of the study information 2021/03/13
Last modified on 2021/09/14

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Basic information
Public title Extraction of factors affecting the effect of Occupational Therapy Intervention Process Model on stroke patients
Acronym Effect of OTIPM
Scientific Title Extraction of factors affecting the effect of Occupational Therapy Intervention Process Model on stroke patients
Scientific Title:Acronym Effect of OTIPM
Region
Japan

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

Objectives
Narrative objectives1 In this study, we examine the efficacy of a treatment approach based on OTIPM for stroke patients. We also examine whether the intervention could bring about an improvement in occupational performance and subjective experience in the stroke patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes AMPS

Functional Independence Measure (FIM), The Assessment of Motor and Process Skills (AMPS), Canadian occupation performance Measure (COPM), Collaborative Relationship Scale (CRS), Stroke Motor Dysfunction Severity Scale (JSS-M) before and after OTIPM intervention -M) is measured and entered in the "evaluation sheet" as the evaluation result. The evaluation before and after the intervention should be within 3 days before and after the OTIPM. Only CRS evaluation will be performed after setting goals with an occupational therapist.
Key secondary outcomes COPM,JSS-M,FIM

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 OTIPM

The OTIPM intervention program is delivered for 20 minutes to 1hr daily, 5 days/wk. Each participant is treated under the guidance of an occupational therapist. After 5 days/wk of intervention each participant was assessed again using the COPM, AMPS, FIM, JSS-M, and CRS. All the interventions are planned and conducted by occupational therapist who is trained and calibrated in the administration of the AMPS completed all preand post assessments. The occupational therapist's main intervention method is OTIPM, and the other intervention methods (such as biomechanical models) are within half the occupational therapist's treatment time .
Interventions/Control_2
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
80 years-old >=
Gender Male and Female
Key inclusion criteria We recruite hospitalised patients from hospitals throughout Japan using convenience sampling.

The subacute phase of stroke generally consists of a period of 7 to 90 days after injury, but this study includes those 30 days over after stroke to avoid inclusion of participants in the acute phase .

The inclusion criteria were as follows: age, 20 80years; and with a first stroke (30days from stroke onset and not indicate rapidly improves motor performance) , and 2 they could understand and sign the relevant informed consent forms.


Key exclusion criteria The exclusion criteria were as follows: 1.patients who do not accept client centred practice; 2.patients with difficulty to follow the procedures or understand the instructions; 3. major cognitive deficits (24 points on the Mini-Mental State Examination) 4. severe aphasia ; 4.pain or sensory disorders severe enough to interfere with participation in treatment ; 5. clients who may have no desire to set their own goals, 6. clients who cannot convey their worries to occupational therapists, 7. client goals that are different from those of the health care team, and 8. clients that are simply indifferent to almost all choices. Initial data from any individual who not maintain his or her appointments during OTIPM intervention would be eliminated from the study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yuki
Middle name
Last name Choji
Organization Toyama rehabilitation medical health and welfare college
Division name Occupational therapy
Zip code 930-0083
Address 4-4-5,sougawa,toyama city
TEL 076-491-1177
Email choujiyuki@gmail.com

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Choji
Organization Toyama rehabilitation medical health and welfare college
Division name Occupational therapy
Zip code 930-0083
Address 4-4-5,sougawa,toyama city
TEL 076-491-1177
Homepage URL
Email choujiyuki@gmail.com

Sponsor
Institute Toyama rehabilitation medical health and welfare college
Institute
Department

Funding Source
Organization This study was supporte financially by the Policy-Based Medical Services Foundation, Japan.
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nigata rehabilitation university
Address 2-16,murakami city,Niigata
Tel 0254-56-8292
Email edu@nur.ac.jp

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
2021 Year 03 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 16
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
2021 Year 03 Month 13 Day
Date of IRB
2020 Year 09 Month 14 Day
Anticipated trial start date
2021 Year 03 Month 16 Day
Last follow-up date
2021 Year 09 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 13 Day
Last modified on
2021 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049792

Research Plan
Registered date File name
2021/09/11 研究計画書.doc

Research case data specifications
Registered date File name
2021/09/11 仕様書.docx

Research case data
Registered date File name
2021/09/11 症例データ.xlsx


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