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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010277
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute JASMITT clinical trial office, Department of Neurology, Nagoya University Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.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


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