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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010896
Receipt No. 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

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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
Email 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
Email y.okada@kio.ac.jp

Sponsor
Institute Kio University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012751

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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