UMIN-CTR Clinical Trial

Basic information
Public title	Goal setting enhances intrinsic motivation of stroke patients
Acronym	Goal setting enhances intrinsic motivation of stroke patients
Scientific Title	Goal setting enhances intrinsic motivation of stroke patients
Scientific Title:Acronym	Goal setting enhances intrinsic motivation of stroke patients
Region	Japan

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

Objectives
Narrative objectives1	The purpose of the study is to examine whether goal setting facilitates intrinsic motivation of stroke patients to rehabilitative motor task.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	How long patients participate in a voluntary reaching task of 15 min
Key secondary outcomes	1) Apathy scale 2) Depression scale 3) Visual analog scale of motivation 4) Rosenberg Self Esteem Scale

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Experimenter and participant discuss and set a rehabilitation goal. Then, the experimenter explains a relevance of a reaching task to the goal they set before the participant perform the voluntary reaching training.
Interventions/Control_2	Experimenter and participant do not discuss and set a rehabilitation goal before the participant perform a voluntary reaching training.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Stroke patients who are in the Hamamatsu Rehabilitation Hospital 2. Brunnstrom Recovery Stage of the upper limbs and fingers is 4 or more. 3. Patients who have enough cognitive function to degree where they can understand an introduction of the study and perform a voluntary training. 4. Patients who agree to participate in this study 5. Patients who are able to sit on a chair or wheelchair 6. Patients who wish to recover their upper limb or finger function.
Key exclusion criteria	1.Patients whose Brunnstrom Recovery Stage of the upper limbs and fingers is 3 or less. 2.Patients who are not able to understand an introduction of the study or not able to perform a voluntary training due to severe dementia or higher brain dysfunction including aphasia. 3. Patients who have psychiatric disease 4. Patients who are considered to be inappropriate to participate in the study
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Chikako Middle name Last name Sakurai
Organization	Hamamatsu City Rehabilitation Hospital
Division name	Division of Rehabilitation
Zip code	433-8127
Address	1-6-1 Wagoukita Hamamatsu, Shizuoka, JAPAN
TEL	053-471-8331
Email	c.sakurai@sis.seirei.or.jp

Public contact
Name of contact person	1st name Chikako Middle name Last name Sakurai
Organization	Hamamatsu City Rehabilitation Hospital
Division name	Division of Rehabilitation
Zip code	433-8127
Address	1-6-1 Wagoukita Hamamatsu, Shizuoka, JAPAN
TEL	053-471-8331
Homepage URL
Email	c.sakurai@sis.seirei.or.jp

Sponsor
Institute	Hamamatsu City Rehabilitation Hospital
Institute
Department

Funding Source
Organization	Hamamatsu City Rehabilitation Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hamamatsu University School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hamamatsu City Rehabilitation Hospital
Address	1-6-1 Wagoukita Hamamatsu, Shizuoka, JAPAN
Tel	053-471-8331
Email	c.sakurai@sis.seirei.or.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	浜松市リハビリテーション病院

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 01 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	Enrolling by invitation
Date of protocol fixation	2019 Year 02 Month 01 Day
Date of IRB	2019 Year 03 Month 01 Day
Anticipated trial start date	2019 Year 03 Month 08 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 11 Day
Last modified on	2021 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041168

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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