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Study Accelerometer Signals to Measure Daily Activities (SASMDA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01617512
First Posted: June 12, 2012
Last Update Posted: April 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
TIMC-IMAG
Laboratory TIMA
Clinical Investigation Centre for Innovative Technology Network
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble
  Purpose
The purpose of this study is to determine if it is possible to identify activities in the daily accelerometer measures of a person with urinary disorders.

Condition Intervention
Urinary Disorders Device: LIS302DL accelerometer

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study Accelerometer Signals to Measure Daily Activities: a Pilot Study

Further study details as provided by AdministrateurCIC, University Hospital, Grenoble:

Primary Outcome Measures:
  • Number of patients with urinary disorders for which it is possible to identify automatically activities among all the daily accelerometer data. [ Time Frame: 6 months ]
    Intrinsic characteristics (sensitivity, specificity, ROC curve) of the test for detecting in automated way the activities among all the daily accelerometer data


Secondary Outcome Measures:
  • Score of satisfaction with the use of the medical device, assessed by the patients [ Time Frame: 6 months ]
    Score between 0 and 10, takes into account the feasibility of the proposed approach and the patient felt the importance of this feasibility.


Enrollment: 30
Study Start Date: February 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: LIS302DL accelerometer
    Recording for 24 hours accelerations related to daily physical activity of the patient.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • man
  • patients fitted with artificial urinary sphincter
  • patients affiliated to social security or similar regime

Exclusion Criteria:

  • patient do not speak french
  • patient unable to express his consent
  • patient hospitalize without consent
  • patient under legal protection
  • patient deprived of liberty
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617512


Locations
France
University Hospital
Grenoble, France
Sponsors and Collaborators
AdministrateurCIC
TIMC-IMAG
Laboratory TIMA
Clinical Investigation Centre for Innovative Technology Network
Investigators
Principal Investigator: Alexandre Moreau-gaudry, MD, PhD University Hospital, Grenoble
  More Information

Responsible Party: AdministrateurCIC, principal investigator, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01617512     History of Changes
Other Study ID Numbers: DCIC 1116
First Submitted: December 15, 2011
First Posted: June 12, 2012
Last Update Posted: April 11, 2014
Last Verified: April 2014