UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043608
Receipt number 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 09:00:59

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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 or person

Institute

Toyama rehabilitation medical health and welfare college

Institute

Department

Personal name



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

Value
https://center6.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