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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007772
Receipt No. R000009153
Scientific Title Clinical Application of the Hanger Reflex to the Treatment of Cervical Dystonia
Date of disclosure of the study information 2012/04/16
Last modified on 2015/10/16

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Basic information
Public title Clinical Application of the Hanger Reflex to the Treatment of Cervical Dystonia
Acronym Treatment of Cervical Dystonia by Hanger reflex
Scientific Title Clinical Application of the Hanger Reflex to the Treatment of Cervical Dystonia
Scientific Title:Acronym Treatment of Cervical Dystonia by Hanger reflex
Region
Japan

Condition
Condition Spasmodic torticolli (Cervical dystonia)
Classification by specialty
Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will apply a portable device which induces the hanger reflex and evaluate the efficacy of it for the cervical dystonia patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Evaluate by Toronto Western Spasmodic Torticollis Rating Scale and modified Tsui score after applying the portable device for 3 months.
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 Put on the device for more than 30 minutes per day
For three months
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients diagnosed as the cervical dystonia with mainly rotated symptom.
Key exclusion criteria Patients who don't have the Hanger reflex.
Patients whose medication might be changed due to unstableness of their clinical condition.
Target sample size 54

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Asahi
Organization University of Toyama
Division name Department of Neurosurgery
Zip code
Address 2630 Sugitani, Toyama, Japan
TEL 076-434-7348
Email takashi-tym@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Asahi
Organization Toyama university hospital
Division name Department of Neurosurgery
Zip code
Address 2630 Sugitani, Toyama, Japan
TEL 076-434-7348
Homepage URL
Email takashi-tym@umin.ac.jp

Sponsor
Institute University of Toyama
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 富山大学附属病院(富山県)、山口大学附属病院(山口県)、順天堂大学医学部附属浦安病院(千葉県)、順天堂大学医学部附属順天堂医院(東京都)、済生会松山病院(愛媛県)、長崎川棚医療センター(長崎県)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 16 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 04 Month 09 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2015 Year 06 Month 01 Day
Date of closure to data entry
2015 Year 06 Month 01 Day
Date trial data considered complete
2015 Year 06 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 16 Day
Last modified on
2015 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009153

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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