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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036156
Receipt No. R000041168
Scientific Title Goal setting enhances intrinsic motivation of stroke patients
Date of disclosure of the study information 2020/05/01
Last modified on 2021/02/17

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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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