UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the effect and safety of transcutaneous application of carbon dioxide on post-polio syndrome.
Title of the study (Brief title)	The effect of transcutaneous application of CO2 on post-plio syndrome.
Region	Japan

Condition
Condition	Post-Polio Syndrome
Classification by specialty	Neurology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of efficiacy and safety of novel transcutaneous application of carbon dioxide in the patients with post-polio syndrome.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Electromyogram Visual analog scales for coldness, pain, fatigue and general conditions. Muscle power
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	Transcutaneous application of CO2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. patients with muscle weakness in post polio syndrome 2. patients who are 20 years old or older 3. patients who can obtain informed consent with written by themselves or regal representive.
Key exclusion criteria	1.Patients with arteriosclerosis obliterans (Fontaine III-IV) 2.Patients with chronic heart failure (NYHA IV) 3.Possibility of pregnancy 4.Respiratory failure (%VC60% or less) 5. Severe anemia (Hb 7.0 g/dl or less 6.Large skin ulcer or severe skin disorder 7.Researcher's decision of unsuitable
Target sample size	10

Research contact person
Name of lead principal investigator	Yoshitada Sakai
Organization	Kobe University Graduate School of Medicine
Division name	Division of Rehabilitation Medicine
Address	7-5-1 Kusunoki-cho, Chuo-ku , Kobe, Japan
TEL	078-382-6826
Email	yossie@med.kobe-u.ac.jp

Public contact
Name of contact person	Yoshitada Sakai
Organization	Kobe University Graduate School of Medicine
Division name	Division of Rehabilitation Medicine
Address	7-5-1 Kusunoki-cho, Chuo-ku , Kobe, Japan
TEL	078-382-6826
Homepage URL
Email	yossie@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 06 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 06 Month 01 Day
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 04 Month 30 Day
Last modified on	2016 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016042