UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010277 |
|---|---|
| Receipt number | R000011208 |
| Scientific Title | The intervention study of the swallowing exercise in patients with SBMA(spinal and bulbar muscular atrophy) |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2016/04/19 09:19:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The intervention study of the swallowing exercise in patients with SBMA(spinal and bulbar muscular atrophy)
Acronym
swallowing exercise in SBMA
Scientific Title
The intervention study of the swallowing exercise in patients with SBMA(spinal and bulbar muscular atrophy)
Scientific Title:Acronym
swallowing exercise in SBMA
Region
| Japan |
Condition
Condition
spinal and bulbar muscular atrophy (SBMA)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the head lift exercise (Shaker Exercise) in patients with spinal and bulbar muscular atrophy (SBMA)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
severity score of the laryngeal penetration in videofluorography
Key secondary outcomes
1)Pharyngeal and oral barium residue (%) in videofluorography
2)stage transition duration, duration of opening upper esophageal sphincter, laryngeal elevation duration, times of swallowing in videofluorography
3)Dysphagia Function Questionnaire
4)motor functional scales
5)serum examination(serum substance P)
6)measurment of tongue pressure
7)Tongue MRI
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Shaker Exercise
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
1)Patients (males) in a genetic test with number of the CAG repeat of the androgen receptor gene more than 38
2)Patients with muscle weakness due to a lower motor neuron
3)Patients are between20 and 80 years old at the time of the agreement acquisition
4)Patients who are capable of ambulatory hospital visits
5)Patient with written informed consent
Key exclusion criteria
1)Patients who have taken LH-RH agonists, an LH-RH antagonists, testosterone drugs, anti-androgen drugs, estrogen drugs or unapproved drugs within 48 weeks before agreement acquisition and patients who have taken 5-alpha-reductase inhibitors within 24 weeks before agreement acquisition.
2)Patient who have undergone operations(eg. orchiectomy), which reduce serum testosterone levels.
3)Patients who have severe complications.
4)Patients who can not do neck flexion in a decubitus.
5)Patients who have undergone operations of the head and neck including cervical spine.
6)Patients who are not appropriate to participate to the trial.
7)Patients who are unable to undergo videofluorography.
8)Patient who are unable to undergo MRI inspection.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Gen Sobue |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550 Japan
TEL
052-744-2390
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoo Mano |
Organization
Department of Neurology
Division name
JASMITT clinical trial office
Zip code
Address
TEL
052-744-2390
Homepage URL
Sponsor or person
Institute
JASMITT clinical trial office, Department of Neurology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
grants from the Ministry of Health, Labor and Welfare of Japan; and Core Research for Evolutional Science and Technology (CREST) from the Japan Science and Technology Agency (JST)
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
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
名古屋大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 01 | 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 | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 28 | Day |
Date of closure to data entry
| 2013 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 19 | Day |
Last modified on
| 2016 | 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=R000011208
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
