Study Accelerometer Signals to Measure Daily Activities (SASMDA)

This study has been completed.
Sponsor:
Collaborators:
TIMC-IMAG
Laboratory TIMA
Clinical investigation center, Technological innovation
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
  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: Open Label
Primary Purpose: Basic Science
Official Title: Study Accelerometer Signals to Measure Daily Activities: a Pilot Study

Further study details as provided by 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 ] [ 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


Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617512

Locations
France
University Hospital
Grenoble, France
Sponsors and Collaborators
AdministrateurCIC
TIMC-IMAG
Laboratory TIMA
Clinical investigation center, Technological innovation
Investigators
Principal Investigator: Alexandre Moreau-gaudry, MD, PhD CHU Grenoble
  More Information

Additional Information:
No publications provided

Responsible Party: AdministrateurCIC, principal investigator, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01617512     History of Changes
Other Study ID Numbers: DCIC 1116
Study First Received: December 15, 2011
Last Updated: April 10, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on April 23, 2014