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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000013842 |
Receipt No. | R000016042 |
Scientific Title | A study of the effect and safety of transcutaneous application of carbon dioxide on post-polio syndrome. |
Date of disclosure of the study information | 2014/06/01 |
Last modified on | 2016/11/10 |
Basic information | ||
Public title | A study of the effect and safety of transcutaneous application of carbon dioxide on post-polio syndrome. | |
Acronym | The effect of transcutaneous application of CO2 on post-plio syndrome. | |
Scientific Title | A study of the effect and safety of transcutaneous application of carbon dioxide on post-polio syndrome. | |
Scientific Title:Acronym | The effect of transcutaneous application of CO2 on post-plio syndrome. | |
Region |
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Condition | |||
Condition | Post-Polio Syndrome | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kobe University Graduate School of Medicine | ||||||
Division name | Division of Rehabilitation Medicine | ||||||
Zip code | |||||||
Address | 7-5-1 Kusunoki-cho, Chuo-ku , Kobe, Japan | ||||||
TEL | 078-382-6826 | ||||||
yossie@med.kobe-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kobe University Graduate School of Medicine | ||||||
Division name | Division of Rehabilitation Medicine | ||||||
Zip code | |||||||
Address | 7-5-1 Kusunoki-cho, Chuo-ku , Kobe, Japan | ||||||
TEL | 078-382-6826 | ||||||
Homepage URL | |||||||
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) |
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 |
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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 | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016042 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |