UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007772 |
|---|---|
| Receipt number | 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 15:38:00 |
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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
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
takashi-tym@umin.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009153
