UMIN-CTR Clinical Trial

Basic information
Public title	The motivation for rehabilitation in patients with stroke: The content validity of Motivation for rehabilitation scale (MORE scale)
Acronym	The content validity of MORE scale
Scientific Title	The motivation for rehabilitation in patients with stroke: The content validity of Motivation for rehabilitation scale (MORE scale)
Scientific Title:Acronym	The content 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 content validity of items of MORE scale.
Basic objectives2	Others
Basic objectives -Others	Examine the content validity of MORE scale
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Consensus method using Delphi method
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	(Patients subjects) 1. Patient with first-ever stroke admitted to a convalescent rehabilitation ward. 2. The score of MMSE is over 24. 3. Consent to participate in the study. (Medical staff subjects) 1.Career is over 5 years 2.Therapist, Nurse 3. Consent to participate in the study.
Key exclusion criteria	(Patients subjects) 1. Being diagnosed with depression 2. Inappropriate to participate in the study for other reasons judged by patient's physician (Medical staff subjects) 1.Inappropriate to participate in the study for other reasons judged by lead principal investigator
Target sample size	90

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
Institute	Tokyo Bay Rehabilitation Hospital
Institute
Department

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	80
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	To explore the content validity of the items in MORE scale using Delphi method.

Management information
Registered date	2019 Year 04 Month 19 Day
Last modified on	2022 Year 04 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041649