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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | stroke patients | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |