UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035239 |
|---|---|
| Receipt number | R000040152 |
| Scientific Title | Effect of galvanic vestibular stimulation on pushing behavior in stroke patients. |
| Date of disclosure of the study information | 2018/12/13 |
| Last modified on | 2020/07/03 15:16:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of galvanic vestibular stimulation on pushing behavior in stroke patients.
Acronym
Galvanic vestibular stimulation on pushing behavior
Scientific Title
Effect of galvanic vestibular stimulation on pushing behavior in stroke patients.
Scientific Title:Acronym
Galvanic vestibular stimulation on pushing behavior
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the immediate effect of galvanic vestibular stimulation on pushing behavior in storke patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scale for contraversive pushing,
Burke Lateropulsion Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Galvanic vestibular stimulation
Interventions/Control_2
sham stimulation
Interventions/Control_3
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Hemiparesis caused by single stroke between 30 and 180 days prior to study enrollment.
2.Right-handed.
3.No severe cognitive impairment (Mini-Mental State Examination, MMSE >15).
4. Present pushing behavior
Key exclusion criteria
1.Bilateral lesions.
2.Unable to sit on a wheelchair.
3.Unable to understand the task because of aphasia or other cognitive impairment.
4.Heart pacemaker, metallic brain implant , epilepsy, or sensitive skin.
5.Inability to give informed consent form.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Nakamura |
Organization
Nishiyamato Rehabilitaiton Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
3-2-2, sasayuridai, Kanmaki-cho, Kitakatsuragi-gun, Nara
TEL
0745-71-6688
n.junji.0923@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junji Nakamura |
Organization
Nishiyamato Rehabilitaiton Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
3-2-2, sasayuridai, Kanmaki-cho, Kitakatsuragi-gun, Nara
TEL
0745-71-6688
Homepage URL
n.junji.0923@gmail.com
Sponsor or person
Institute
Nishiyamato Rehabilitaiton Hospital
Institute
Department
Personal name
Funding Source
Organization
Nishiyamato Rehabilitaiton Hospital
Organization
Division
Category of Funding Organization
Other
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 | 12 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 13 | Day |
Last modified on
| 2020 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040152
