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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002133
Receipt No. R000002606
Scientific Title The effect of press tack needles on the swallowing reflex in the elderly.
Date of disclosure of the study information 2010/04/01
Last modified on 2013/07/02

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Basic information
Public title The effect of press tack needles on the swallowing reflex in the elderly.
Acronym The effect of press tack needles on the swallowing reflex in the elderly.
Scientific Title The effect of press tack needles on the swallowing reflex in the elderly.
Scientific Title:Acronym The effect of press tack needles on the swallowing reflex in the elderly.
Region
Japan

Condition
Condition aspiration pneumonia
Classification by specialty
Medicine in general Pneumology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether acupuncture therapy with press tack needles can improve the swallowing reflex in the elderly.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of swallowing reflex.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Press tack needles on acupoints
Interventions/Control_2 Sham needles on acupoints
Interventions/Control_3 Press tack needles on sham points
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria elder patients with cerebrovascular diseases
Key exclusion criteria patients obviously showing a symptom
of pneumonia
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Seki
Organization Tohoku University Graduate School of Medicine
Division name Department of Traditional Asian Medicine
Zip code
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL 022-717-7185
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Seki
Organization Tohoku University Graduate School of Medicine
Division name Department of Traditional Asian Medicine
Zip code
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Department of Traditional Asian Medicine, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Tohoku University Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information
2010 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
2009 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 29 Day
Last modified on
2013 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002606

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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