UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000036554
Receipt number R000041650
Scientific Title The motivation for rehabilitation in patients with stroke: Internal consistency and criterion validity of Motivation for rehabilitation scale (MORE scale)
Date of disclosure of the study information 2019/04/20
Last modified on 2022/04/21 18:56:21

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Basic information

Public title

The motivation for rehabilitation in patients with stroke: Internal consistency and criterion validity of Motivation for rehabilitation scale (MORE scale)

Acronym

Internal consistency and criterion validity of MORE scale

Scientific Title

The motivation for rehabilitation in patients with stroke: Internal consistency and criterion validity of Motivation for rehabilitation scale (MORE scale)

Scientific Title:Acronym

Internal consistency and criterion validity of MORE scale

Region

Japan


Condition

Condition

Stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To explore Internal consistency and criterion validity of MORE scale.

Basic objectives2

Others

Basic objectives -Others

To explore Internal consistency and criterion validity of new developed motivation scale.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

・Cronbach'alpha in items of MORE scale
・Spearman's correlation coefficient of MORE scale with Self-rating Depression scale, Apathy scale, and Intrinsic Motivation Inventory.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patient with first-ever stroke admitted to a convalescent rehabilitation ward.
2. Within 2 months from onset of stroke.
3. capable to evaluate MORE scale

Key exclusion criteria

1. Cannot follow three step directions.
2.FIM motor score at admission more than 75
3. Being diagnosed with depression
4. Inappropriate to participate in the study for other reasons judged by patient's physician

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Taiki
Middle name
Last name Yoshida

Organization

Tokyo Bay Rehabilitation Hospital

Division name

Department of Rehabilitation

Zip code

2750026

Address

4-1-1 Yatsu, Narashino-shi, Chiba

TEL

047-453-9000

Email

Otr.taiki.yoshida@gmail.com


Public contact

Name of contact person

1st name Taiki
Middle name
Last name Yoshida

Organization

Tokyo Bay Rehabilitation Hospital

Division name

Department of Rehabilitation

Zip code

2750026

Address

4-1-1 Yatsu, Narashino-shi, Chiba

TEL

047-453-9000

Homepage URL


Email

OTR.taiki.yoshida@gmail.com


Sponsor or person

Institute

Tokyo Bay Rehabilitation Hospital

Institute

Department

Personal name



Funding Source

Organization

Tokyo Bay Rehabilitation Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

University of Tsukuba Graduate School of Comprehensive Human Sciences
Graduate school of human sciences, Waseda University.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics committee of Tokyo Bay Rehabilitation Hospital

Address

4-1-1 Yatsu, Narashino-shi, Chiba

Tel

047-453-9000

Email

shinsakai@wanreha.net


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

東京湾岸リハビリテーション病院(千葉県)
Tokyo Bay Rehabilitation Hospital(Chiba)


Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 20 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

150

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

2016 Year 10 Month 13 Day

Date of IRB

2016 Year 10 Month 13 Day

Anticipated trial start date

2016 Year 10 Month 13 Day

Last follow-up date

2021 Year 08 Month 03 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We explore Cronbach'alpha of items in MORE scale for examining internal consistency.
We explore criterion validity of MORE scale with Self-rating Depression scale, Apathy scale and Intrinsic Motivation Inventory by Spearman's correlation coefficient.


Management information

Registered date

2019 Year 04 Month 19 Day

Last modified on

2022 Year 04 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041650


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name