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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014