UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of vestibular stimulation applied to the stroke patients in static sitting position.
Title of the study (Brief title)	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	Yohei Tomioka
Organization	Tokyo Bay Rehabilitation Hospital
Division name	Rehabilitation
Address	4-1-1 Yatsu,Narashino-shi,Chiba
TEL	0474539000
Email	ytomi@keio.jp

Public contact
Name of contact person	Yohei Tomioka
Organization	Tokyo Bay Rehabilitation Hospital
Division name	Rehabilitation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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