UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001956 |
|---|---|
| Receipt number | R000002385 |
| Scientific Title | Interhemispheric interaction before and after motor task. |
| Date of disclosure of the study information | 2009/05/11 |
| Last modified on | 2013/05/11 13:41:41 |
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Basic information
Public title
Interhemispheric interaction before and after motor task.
Acronym
Interhemispheric interaction before and after motor task.
Scientific Title
Interhemispheric interaction before and after motor task.
Scientific Title:Acronym
Interhemispheric interaction before and after motor task.
Region
| Japan |
Condition
Condition
Stroke patients, and Healthy person
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to estimate the change of interhemispheric inhibition by bilateral and unilateral hand exercises in stroke patient and healthy volunteer.
Basic objectives2
Others
Basic objectives -Others
The change of ineterhemispheric inhibition that is measured by Transcranial magnetic stimulation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interhemispheric Inhibition which is measured by Transcranial magnetic stimulation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Bilateral hand extension task for ten minutes
Interventions/Control_2
Unilateral hand extension task for ten minutes.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Stroke patients
1) Stroke patients whose ages were over 20 and less than 65 years old.
2) Patients with hemiparesis due to first stroke attack.
3) After at least one month from attack.
4) Patients without severe sensory dysfunctions and cognitive disorder.
Healthy volunteer
1) Healthy volunteer whose ages were over 20 and less than 65 years old.
2) Healthy volunteer without neuromuscular diseases.
Key exclusion criteria
1) Patients who have digital devise, for example pacemaker or V-P shunt, inside a body.
2) Patients with complication of epilepsy.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaoru Honaga |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi, Shinjukuku, Tokyo, Japan
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaoru Honaga |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi, Shinjukuku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
Sponsor or person
Institute
Department of Rehabilitation Medicine Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 05 | Month | 11 | 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
Completed
Date of protocol fixation
| 2009 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 11 | Day |
Last modified on
| 2013 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002385
