UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029354 |
|---|---|
| Receipt number | 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 17:03:01 |
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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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033539
