Electromyographic (EMG) and Mechanomyographic (MMG) Comparison (EMG-MMG)
This study has been completed.
Sponsor:
University Hospital, Grenoble
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00942370
First received: July 2, 2009
Last updated: July 31, 2009
Last verified: July 2009
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 2, 2009 | ||||
| Last Updated Date | July 31, 2009 | ||||
| Start Date ICMJE | July 2009 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Delay between the detection by mechanomyography (MMG) of rectus abdominis contraction and the detection of cough in cough effort [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00942370 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Lower and upper spectral band frequencies values for which the majority of the MMG signal is present, thresholds for detection of rectus abdominis contraction by mechanical myography [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Electromyographic (EMG) and Mechanomyographic (MMG) Comparison | ||||
| Official Title ICMJE | Comparison of Electromyographic With Mechanomyographic Signals of Rectus Abdominis | ||||
| Brief Summary | The purpose of this study is to assess the delay between the detection (by mechanomyography-MMG) of rectus abdominis contraction and the detection of cough in cough effort. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Healthy volunteers |
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| Condition ICMJE | Stress Urinary Incontinence | ||||
| Intervention ICMJE | Device: non invasive mechanomyographic device based on a 3 axes accelerometer
This biomedical research consists specifically in the simultaneous acquisition of:
These acquisitions will be conducted on 16 healthy volunteers according to a standardized protocol, at rest and during voluntary cough and various physical exercises often resulting in urinary leakage in the incontinent person. |
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| Study Group/Cohort (s) | accelerometric device
Intervention: Device: non invasive mechanomyographic device based on a 3 axes accelerometer |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 16 | ||||
| Completion Date | July 2009 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00942370 | ||||
| Other Study ID Numbers ICMJE | DCIC 0904 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Alexandre Moreau-Gaudry, University Hospital of Grenoble | ||||
| Study Sponsor ICMJE | University Hospital, Grenoble | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Grenoble | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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