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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028480
Receipt No. R000032601
Scientific Title Effect of the vibratory stimulation on the ataxia of the upper limb (before-after trial)
Date of disclosure of the study information 2017/08/03
Last modified on 2017/08/01

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Basic information
Public title Effect of the vibratory stimulation on the ataxia of the upper limb (before-after trial)
Acronym the vibratory stimulation on the ataxia
Scientific Title Effect of the vibratory stimulation on the ataxia of the upper limb (before-after trial)
Scientific Title:Acronym the vibratory stimulation on the ataxia
Region
Japan

Condition
Condition central neurological disease
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of the vibratory stimulation on the ataxia of the upper limb objectively.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes fluctuation of movement during pointing
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 the vibratory stimulation of the biceps, wrist flexor muscles, finger flexor muscles
Interventions/Control_2
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
15 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria the patients with ataxia of upper limb
Key exclusion criteria dimetia, trouble of skin, severe contraction, severe neuropathicpain, severe hemiplegia
Target sample size 10

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Seiji Etoh
Organization Graduate School of Medical and Dental Sciences, Kagoshima University
Division name Department of Rehabilitation and Physical Medicine
Zip code
Address Takachiho 3930-7, Makizono-cho, Kirishima-City, Kagoshima, Japan
TEL 0995782538
Email etohs@m2.kufm.kagoshima-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Seiji Etoh
Organization Graduate School of Medical and Dental Sciences, Kagoshima University
Division name Department of Rehabilitation and Physical Medicine
Zip code
Address Takachiho 3930-7, Makizono-cho, Kirishima-City, Kagoshima, Japan
TEL 0995782538
Homepage URL
Email etohs@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute Graduate School of Medical and Dental Sciences, Kagoshima University
Institute
Department

Funding Source
Organization Graduate School of Medical and Dental Sciences, Kagoshima University
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 03 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
Anticipated trial start date
2017 Year 08 Month 03 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 08 Month 01 Day
Last modified on
2017 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032601

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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