UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005942 |
|---|---|
| Receipt number | R000007021 |
| Scientific Title | Clinical application of the hanger reflex to the treatment of cervical dystonia |
| Date of disclosure of the study information | 2011/07/06 |
| Last modified on | 2015/04/19 16:52:53 |
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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 using hanger reflex
Scientific Title
Clinical application of the hanger reflex to the treatment of cervical dystonia
Scientific Title:Acronym
Treatment of cervical dystonia using hanger reflex
Region
| Japan |
Condition
Condition
cervical dystonia
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will apply a portable device which induces the hanger reflex and confirm the efficacy to 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 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
Wear 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed as the cervical dystonia
Key exclusion criteria
Patients not diagnosed as the cervical dystonia
Target sample size
5
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Toyama university hospital
Division name
Department of Neurosurgery
Zip code
Address
Toyama university hospital
TEL
076-434-2281
Homepage URL
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
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 06 | 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
Two patients participated in this clinical study.
One improved, the other did not change.
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
| 2011 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 05 | Month | 01 | Day |
Other
Other related information
Because the number of the participant was small, this study will be succeeded to the multicenter study.
Management information
Registered date
| 2011 | Year | 07 | Month | 06 | Day |
Last modified on
| 2015 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007021
