UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031249 |
|---|---|
| Receipt number | R000035680 |
| Scientific Title | Effect of vestibular stimulation on subjective visual vertical in patients with hemiparetic stroke |
| Date of disclosure of the study information | 2018/02/11 |
| Last modified on | 2018/05/13 10:38:10 |
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Basic information
Public title
Effect of vestibular stimulation on subjective visual vertical in patients with hemiparetic stroke
Acronym
Effect of vestibular stimulation on subjective visual vertical in patients with hemiparetic stroke
Scientific Title
Effect of vestibular stimulation on subjective visual vertical in patients with hemiparetic stroke
Scientific Title:Acronym
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
| 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
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
ytomi@keio.jp
Sponsor or person
Institute
Tokyo Bay Rehabilitation Hospital
Institute
Department
Personal name
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
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 |
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
| 2018 | Year | 02 | Month | 11 | Day |
Last modified on
| 2018 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035680
