UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010896 |
|---|---|
| Receipt number | R000012751 |
| Scientific Title | Effects of galvanic vestibular stimulation on postural abnormalities in patients with Parkinson's disease A randomized controlled trial |
| Date of disclosure of the study information | 2013/06/07 |
| Last modified on | 2015/06/07 15:07:21 |
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Basic information
Public title
Effects of galvanic vestibular stimulation on postural abnormalities in patients with Parkinson's disease A randomized controlled trial
Acronym
Galvanic vestibular stimulation for postural abnormalities in Parkinson's disease
Scientific Title
Effects of galvanic vestibular stimulation on postural abnormalities in patients with Parkinson's disease A randomized controlled trial
Scientific Title:Acronym
Galvanic vestibular stimulation for postural abnormalities in Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the immediate effects of galvanic vestibular sitmulation on postural abnormalities in patients with Parkinson's disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Trunk flexion angle, trunk lateral flexion angle
Key secondary outcomes
Center of pressure position during quiet standing and galvanic body sway test
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. 1 to 4 on Hoehn and Yahr scale
2. can stand unassisted more than 5 minutes
3. Definition of camptocormia
Marked (minimum 45 degrees) trunk fexion in the sagittal plane
originating in the thoracolumbar spine, almost complete
resolution in the supine position
4. Definition of pisa syndrome
Marked (minimum ten degrees) lateral trunk fexion that can be almost completely alleviated by passive mobilisation or supine positioning
Key exclusion criteria
1. History of other neurological disorders, severe orthopedic disease and vestibular disorders
2. Presence of cardiac pacemaker
3. Presence of deep brain stimulation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yohei Okada |
Organization
Kio University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
Address
4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL
+81-745-54-1601
y.okada@kio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Okada |
Organization
Kio University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
Address
4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL
+81-745-54-1601
Homepage URL
y.okada@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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
畿央大学（奈良県）西大和リハビリテーション病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/25793635
Number of participants that the trial has enrolled
Results
The anterior bending angles in both the eyes-open and the eyes-closed conditions were significantly reduced after the GVS. The amount of change in the eyes-closed condition post-GVS was significantly larger than that by sham stimulation. The amount of change in anterior bending angles in the GVS condition was not significantly correlated with Unified Parkinson's Disease Rating Scale motor score, disease duration, the duration of the postural deformities, and the anterior bending angles before the GVS. Binaural monopolar GVS might improve anterior bending posture in PD patients, irrespective of the duration and the severity of disease and postural deformities. Binaural monopolar GVS might be a novel treatment strategy to improve anterior bending posture in PD.
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
Main results already published
Date of protocol fixation
| 2013 | Year | 06 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 05 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 07 | Day |
Last modified on
| 2015 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012751
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| Registered date | File name |
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| Registered date | File name |
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