UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036156 |
|---|---|
| Receipt number | 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 11:33:44 |
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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
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
c.sakurai@sis.seirei.or.jp
Sponsor or person
Institute
Hamamatsu City Rehabilitation Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041168
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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