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Study Accelerometer Signals to Measure Daily Activities (SASMDA)

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ClinicalTrials.gov Identifier: NCT01617512
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : April 11, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Urinary Disorders Device: LIS302DL accelerometer

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : February 2012
Primary Completion Date : July 2013
Study Completion Date : July 2013
Arms and Interventions

Intervention Details:
    Device: LIS302DL accelerometer
    Recording for 24 hours accelerations related to daily physical activity of the patient.

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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

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

University Hospital
Grenoble, France
Sponsors and Collaborators
Laboratory TIMA
Clinical Investigation Centre for Innovative Technology Network
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 Posted: June 12, 2012    Key Record Dates
Last Update Posted: April 11, 2014
Last Verified: April 2014