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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029354
Receipt No. R000033539
Scientific Title The effect of vestibular stimulation applied to the stroke patients in static sitting position.
Date of disclosure of the study information 2017/09/29
Last modified on 2017/09/29

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Basic information
Public title The effect of vestibular stimulation applied to the stroke patients in static sitting position.
Acronym The effect of vestibular stimulation applied to the stroke patients in static sitting position.
Scientific Title The effect of vestibular stimulation applied to the stroke patients in static sitting position.
Scientific Title:Acronym The effect of vestibular stimulation applied to the stroke patients in static sitting position.
Region
Japan

Condition
Condition Stroke
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To Make assessment of the change which occurs during the vestibular stimulation is done to the stroke patients who are in sitting position
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of center of gravity in sitting positon before and during the vestibular stimulation is done
Key secondary outcomes The change of subjective visual vertical before and during the vestibular stimulation is done

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Right anode stimulation is done 3 times per day successively. The duration of stimulation is 35 seconds at a time.
Interventions/Control_2 Left anode stimulation is done 3 times per day successively. The duration of stimulation is 35 seconds at a time.
Interventions/Control_3 Sham stimulation is done 3 times per day successively. The duration of stimulation is 35 seconds at a time.
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 Primary stroke patient with supra tentorial lesion who can sit more than 35 seconds without any support
Key exclusion criteria Person who can't understand the instruction of the test, person who has orthopedic disease or who has experienced surgery which has impact on the sitting posture, person who has otolaryngologic disease which has influence on vestibular nerve, person who has previous illness of epilepsy, person who has been implanted pacemaker, VP shunt or other kind of electronic device
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yohei Tomioka
Organization Tokyo Bay Rehabilitation Hospital
Division name Rehabilitation
Zip code
Address 4-1-1 Yatsu,Narashino-shi,Chiba
TEL 0474539000
Email ytomi@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yohei Tomioka
Organization Tokyo Bay Rehabilitation Hospital
Division name Rehabilitation
Zip code
Address 4-1-1 Yatsu,Narashino-shi,Chiba
TEL 0474539000
Homepage URL
Email ytomi@keio.jp

Sponsor
Institute Tokyo Bay Rehabilitation Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 東京湾岸リハビリテーション病院

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 29 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
2012 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 29 Day
Last modified on
2017 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033539

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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