Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study Accelerometer Signals to Measure Daily Activities (SASMDA)

This study has been completed.
Sponsor:
Collaborators:
TIMC-IMAG
Laboratory TIMA
Clinical Investigation Centre for Innovative Technology Network
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01617512
First received: December 15, 2011
Last updated: April 10, 2014
Last verified: April 2014

December 15, 2011
April 10, 2014
February 2012
July 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Intrinsic characteristics (sensitivity, specificity, ROC curve) of the test for detecting in automated way the activities among all the daily accelerometer data
Same as current
Complete list of historical versions of study NCT01617512 on ClinicalTrials.gov Archive Site
Score of satisfaction with the use of the medical device, assessed by the patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Score between 0 and 10, takes into account the feasibility of the proposed approach and the patient felt the importance of this feasibility.
Same as current
Not Provided
Not Provided
 
Study Accelerometer Signals to Measure Daily Activities (SASMDA)
Study Accelerometer Signals to Measure Daily Activities: a Pilot Study

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Urinary Disorders
Device: LIS302DL accelerometer
Recording for 24 hours accelerations related to daily physical activity of the patient.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01617512
DCIC 1116
Yes
AdministrateurCIC, University Hospital, Grenoble
AdministrateurCIC
  • TIMC-IMAG
  • Laboratory TIMA
  • Clinical Investigation Centre for Innovative Technology Network
Principal Investigator: Alexandre Moreau-gaudry, MD, PhD CHU Grenoble
University Hospital, Grenoble
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP