UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001956
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Department of Rehabilitation Medicine Keio University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002385

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.