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Electromyographic (EMG) and Mechanomyographic (MMG) Comparison (EMG-MMG)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00942370
First received: July 2, 2009
Last updated: July 31, 2009
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention
Stress Urinary Incontinence
 Device: non invasive mechanomyographic device based on a 3 axes accelerometer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Comparison of Electromyographic With Mechanomyographic Signals of Rectus Abdominis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 16
Study Start Date: July 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
accelerometric device Device: non invasive mechanomyographic device based on a 3 axes accelerometer

This biomedical research consists specifically in the simultaneous acquisition of:

  • EMG and MMG Signals of rectus abdominis of the abdomen,
  • Respiratory flow,
  • An electrocardiogram (ECG).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy volunteers

Criteria

Inclusion Criteria:

  • More or equal than 18 years old
  • Patient affiliated to social security or similarly regime
  • Healthy volunteer
  • BMI less than 30

Exclusion Criteria:

  • Pregnant women and lactating mothers
  • Ward of court or under guardianship
  • Adult unable to express their consent or person under legal protection
  • Person deprived of freedom by judicial or administrative decision
  • Person hospitalized without their consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942370

Locations
France
Clinical Investigation Center - INSERM - University Hospital of Grenoble
Grenoble, France
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Alexandre Moreau-Gaudry, MD, PhD University Hospital, Grenoble
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Alexandre Moreau-Gaudry, University Hospital of Grenoble
ClinicalTrials.gov Identifier: NCT00942370     History of Changes
Other Study ID Numbers: DCIC 0904
Study First Received: July 2, 2009
Last Updated: July 31, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
mechanography
electromyography
effort cough

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013