UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of vestibular stimulation on subjective visual vertical in patients with hemiparetic stroke
Title of the study (Brief title)	Effect of vestibular stimulation on subjective visual vertical in patients with hemiparetic stroke
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Neurology Oto-rhino-laryngology Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To know the effect that occurs to the hemiparesis patients by the vestibular stimulation and to know the efficacy of the vestibular stimulation for modifying warped equilibrium sense damaged by the cerebrovascular disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subjective visual vertical
Key secondary outcomes

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	Institution is not considered as adjustment factor.
Blocking
Concealment	Pseudo-randomization

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Bipolar direct current electrical stimulation(1.5mA) is done by setting the electrode on the both side of mastoid to the right hemisphere lesion patients. Three types of stimulation, right-anode, left-anode, sham stimulation are done about 30 seconds at a time. The types of stimulation applied to the subjects are concealed, and the order of stimulations performed are selected pseudo-randomly at each subject. 24 hours have to be past between each stimulation.
Interventions/Control_2	Bipolar direct current electrical stimulation(1.5mA) is done by setting the electrode on the both side of mastoid to the left hemisphere lesion patients. Three types of stimulation, right-anode, left-anode, sham stimulation is done about 30 seconds at a time. The types of stimulation applied to the subjects are concealed, and the order of stimulations performed are selected pseudo-randomly at each subject. 24 hours have to be past between each stimulation.
Interventions/Control_3	Bipolar direct current electrical stimulation(1.5mA) is done by setting the electrode on the both side of mastoid to the left hemisphere lesion patients. Three types of stimulation, right-anode, left-anode, sham stimulation is done about 30 seconds at a time. The types of stimulation applied to the subjects are concealed, and the order of stimulations performed are selected pseudo-randomly at each subject. 24 hours have to be past between each stimulation.
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	When it comes to patients, who suffered from hemiparesis by the first occurrence of stroke with supratentorial lesion at one side of the lobe, and who can sit still for about 30 seconds without any hold.
Key exclusion criteria	Who cannot be aware of the order for the experiments, and who have orthopedic disease or experience of orthopedic operation before, neurologic disease except the current stroke, otolaryngologic disease which has a influence for the vestibular function, past history of head injury, implanted electric devices such as pacemaker or VP shunt.
Target sample size	50

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

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 11 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	2018 Year 02 Month 11 Day
Last modified on	2018 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035680